Frequently Asked Questions
2. What are the alternatives to Single-Day Targeted Intraoperative Radiotherapy?
3. Must a patient live in Los Angeles to participate in the Targit Trial?
5. Can my patient participate in the Targit Trial if she has already had a lumpectomy?
7. What kind of follow-up is needed if a patient participates in the Targit Trial?
10. What are the advantages of Single-Day Targeted Intraoperative Radiotherapy?
11. What are the disadvantages of Single-Day Targeted Intraoperative Radiotherapy?
12. What are the possible side effects and risks of Single-Day Targeted Intraoperative Radiotherapy?
14. When will the results of the Targit Trial be known?
15. Will my patient's medical information be kept private if she participates in the Targit Trial?
16.What are the costs of participating in the Targit Trial?
17. What are my patient's rights as a participant in the Targit Trial?
18. Who do I call if I have a question about or problems related to the Targit Trial?
1. Can my patient obtain Single-Day Targeted Intraoperative Radiotherapy without participating in the Targit Trial?
Single-Day Targeted Intraoperative Radiotherapy may be obtained in 2 ways:
- Single-Day Targeted Intraoperative Radiotherapy administered as the complete radiotherapy treatment
- Targeted Intraoperative Radiotherapy administered as a "Boost" to the lumpectomy cavity to be followed by Conventional Radiotherapy.
Single-Day Targeted Intraoperative Radiotherapy is currently being evaluated as an alternative to Conventional Postoperative Radiotherapy and may only be obtained by participating in the Targit Trial. Half of the participants in the Targit Trial will receive Single-Day Targeted Intraoperative Radiotherapy at the time of surgery following removal of the breast cancer. The other half will receive Conventional Postoperative Radiotherapy given over a 6-7 week period after recovering from surgery.
Targeted Intraoperative Radiotherapy can also be administered as a "Boost" to the lumpectomy cavity to be followed by Conventional Radiotherapy. Standard treatment for patients undergoing lumpectomy is to receive Conventional Postoperative Radiotherapy to the entire breast after surgery. In addition to Conventional Postoperative Radiotherapy, nearly all patients under age 60 also receive an additional dose of radiotherapy that is confined to the part of the breast that contained the breast cancer. The additional treatment is called a “boost” and is usually given as a daily treatment for 1 week after completing a 6-week course of Conventional Postoperative Radiotherapy. Receiving the boost treatment given by Targeted Intraoperative Radiotherapy will not only improve the accuracy of the boost radiotherapy, but also shorten radiotherapy treatment by one week, saving 1 week of visits to the radiation oncology facility. Intraoperative radiotherapy given as a “boost” has been used for more than a decade in Europe and is a safe and reliable method for administering boost radiotherapy.
2. What are the alternatives to Single-Day
Targeted Intraoperative Radiotherapy?
Several alternatives to Single-Day Targeted Intraoperative Radiotherapy are available at USC and may be administered to women not participating in the Targit Trial. These alternatives are listed below:
- Conventional Postoperative Radiotherapy. Conventional Postoperative Radiotherapy is the standard treatment that has been used for many years for patients undergoing lumpectomy for breast cancer. At USC, Conventional Postoperative Radiotherapy is administered to the whole breast over a 6-week period followed by 1 additional week of “boost” radiotherapy confined to the part of the breast that contained the breast cancer. Your patient can obtain Conventional Postoperative Radiotherapy without participating in the Targit Trial.
- Mammosite Balloon Catheter Radiotherapy. Mammosite Balloon Catheter Radiotherapy is type of radiotherapy administered through a catheter (tubing) that is inserted into the breast during or after surgery. The radiation treatment is given 2 times a day for 5 days and is designed to treat only the portion of the breast that contained the breast cancer. This reduces the radiation treatment time from 6 weeks to 1 week. Mammosite Balloon Catheter Radiotherapy may be obtained without participating in the Targit Trial.
- 3-D Conformal Radiotherapy. 3-D Conformal Radiotherapy is a type of partial breast irradiation that is admistered externally, using radiation that passes through the skin to enter the breast. Using 4 or 5 intersecting beams of radiation, the radiotherapy treatment is focused on the part of the breast that contained the breast cancer. This treatment is given on a daily basis for a total of 2 weeks.
3. Must my patient live in Los Angeles to participate in the Targit Trial?
You patient does not need to live in Los Angeles to participate in the Targit Trial. However, she will need to be evaluated at USC to determine if she is eligible for the Targit Trial. This evaluation will include a visit with the surgeon and radiation oncologist. Additional radiology studies (mammograms, ultrasounds, and/or breast MRI) may also be requested prior to determining eligibility for the study.
If she qualifies for the Targit Trial and is willing to participate in this study, she will be assigned to receive either Single-Day Targeted Intraoperative Radiotherapy or Conventional Postoperative Radiotherapy. If she is assigned to the Single-Day Targeted Intraoperative Radiotherapy treatment, she will need to undergo breast surgery and Intraoperative Radiotherapy at USC. If she is assigned to the Conventional Postoperative Radiotherapy treatment, she can choose to receive this treatment at USC or she may choose to receive this treatment at a radiation oncology facility near her home.
Finally, regardless of where she lives or which type of radiotherapy she receives, participation in the Targit Trial requires that she follow-up with USC doctors every 6 months for the first 5 years, and then annually for an additional 5 years. Each participant is expected to provide her own travel and accommodations for these follow-up visits. Any medical costs associated with these follow-up visits will be billed to her insurance company or to Medicare. If she plans to move and will no longer be able to return to USC for follow-up, if is important that she notifies her doctors at USC so that they can maintain contact with her.
During each check-up visit, you will be examined by the surgeon and radiation oncologist as well as receive mammograms and any additional needed studies. The purpose of these check-ups is to confirm that you are doing well to be evaluate you for the possibility of a breast cancer recurrence.
4. If my patient is assigned to receive
Conventional Postoperative Radiotherapy, is she required to receive the
radiotherapy at USC?
One very convenient aspect of the Targit Trial is that your patient be allowed to receive Conventional Postoperative Radiotherapy at a radiation oncology facility near her home if she have been assigned to that treatment. The radiation oncologist at USC will contact your patient's local facility to confirm that it can administer Conventional Postoperative Radiotherapy in a way that is required by the Targit Trial.
5. Can my patient participate in the Targit
Trial if she has already had a lumpectomy?
Yes. Your patient can still participate in the Targit Trial even if she has already had a lumpectomy within the past 6 weeks for invasive breast cancer. To determine if she is eligible, she will need to be evaluated by a surgeon and radiation oncologist at USC. This evaluation will include physical examination, review of her mammograms and ultrasound, and review of pathology results. Additional radiology studies (mammograms, ultrasounds, and/or breast MRI) may also be requested prior to determining eligibility for the study. If she is eligible for participation in the Targit Trial, she will be randomly assigned to receive either Single-Day Targeted Intraoperative Radiotherapy or Conventional Postoperative Radiotherapy. If she is assigned to the Single-Day Targeted Intraoperative Radiotherapy treatment, she will need to undergo one additional breast operation so that this treatment may be administered. On the other hand, if she is assigned to the Conventional Postoperative Radiotherapy treatment, she will receive this treatment over a 6-7 week period after recovering from surgery. She can obtain this Conventional Postoperative Radiotherapy at USC or at a radiation oncology center near her home.
6. If my patient has already had a lumpectomy, how will her pathology results influence her eligibility for the Targit Trial?
If your patient has already had a lumpectomy, her pathology results and slides will need to be reviewed at USC to determine if she is eligible for participation in the Targit Trial. Based on her pathology results, there are 3 possible outcomes:
Scenario #1:
Her pathology results will be acceptable and she may then be
enrolled in the Targit Trial. If she is assigned to the Single-Day Targeted
Intraoperative Radiotherapy treatment, she will need to undergo additional
operation under general anesthesia so that this treatment may be given
in the operating room. At the time she receives this treatment, the surgeon
will need to temporarily reshape her breast tissue so that Intraoperative
Radiotherapy may be given properly. On the other hand, if she is assigned
to the Conventional Postoperative Radiotherapy treatment, she will receive
this treatment after recovering from surgery. She may receive Conventional
Postoperative Radiotherapy at USC or at a radiation oncology facility
near her home.
Scenario #2:
The pathology report will indicate that Single-Day Targeted Intraoperative
Radiotherapy is not appropriate for your patient as the sole radiotherapy
treatment for her breast cancer. Therefore, she cannot participate in
the Targit Trial. If this happens, she will have four radiotherapy options:
Option #1: Conventional
Postoperative Radiotherapy given to the entire breast over a 6-7 week
period after she has recovered from surgery
Option #2: Partial Breast
Radiotherapy given by Mammosite Balloon Catheter Radiotherapy given as
twice daily treatment for 5 days.or 3-D Conformal Radiotherapy given over
14 days.
Option #3: Partial Breast
Radiotherapy given as 3-D Conformal Radiotherapy. This form of external
beam radiotherapy is given as a daily treatment for 2 weeks.
Option #4: Intraoperative
Radiotherapy given as a “boost” treatment at the time of surgery
to be followed by Conventional Postoperative Radiotherapy given to the
remaining breast after she has recovered from surgery. Receiving a “boost”
treatment in the operating room will reduce her Conventional Postoperative
Radiotherapy treatment by 1 week.
Scenario #3: Her pathology report indicates that she will need to have additional breast tissue removed in order to receive intraoperative radiotherapy as her sole radiotherapy treatment. This scenario usually applies to someone whose tumor has been excised but whose surgical margins are too close. The USC Targit Trial protocol requires surgical margins that are clear by 3 millimeters or more from the cancer. This provision minimizes the chances of a local recurrence. Therefore, if your patients pathology results reveals margins less than 3 millimeters wide, and if she meets the enrollment criteria she will be permitted to participate in the Targit Trial if she is willing to undergo a reexcision of her lumpectomy site to achieve wider margins. If she is randomized to receive Single-Day Targeted Intraoperative Radiotherapy, the radiotherapy treatment will be administered during surgery after additional breast tissue has been removed. On the other hand, if she is randomized to the Conventional Postoperative Radiotherapy treatment, she will first undergo removal of additional breast tissue then receive Conventional Postoperative Radiotherapy after she has recovered from surgery.
7. What kind of follow-up is needed if my patient participates in the Targit Trial?
Regardless of where your patient lives or which type of radiotherapy she receives, participation in the Targit Trial requires that she follow-up with the USC doctors every 6 months for the first 5 years, and then annually for an additional 5 years. Each participant is expected to provide her own travel and accommodations for these follow-up visits. Any medical costs associated with these follow-up visits will be billed to her insurance company or to Medicare. If she plans to move and will no longer be able to return to USC for follow-up, if is important that she notifies her doctors at USC so that they can maintain contact with her and her new doctors. Special provisions might be made for individual patients who might not be able to maintain this follow-up schedule.
8. What happens if my patient receives Single-Day Targeted Intraoperative Radiotherapy, but after surgery her pathology results show that the breast cancer has not been adequately removed?
If you patient has received intraoperative radiotherapy but is found to have an inadequately removed breast cancer, the surgeon and radiation oncologist will advise her to undergo additional breast surgery. If the surgeon believes that she can successfully undergo a second lumpectomy, she will undergo a second operation but you will not be given intraoperative radiotherapy a second time. Instead, she will be advised to receive Conventional Postoperative Radiotherapy after recovering from surgery.
To ensure that you patient is a good candidate for the Targit Trial, the surgeon and radiation oncologist will use a range of studies to understand the nature and dimensions of cancer within your patients breast. Ideally, this will include breast MRI to define the tumor dimensions and to rule out multifocal, multicentric, or bilateral breast cancer. If will also include axillary lymph node ultrasound to detect lymph node metastasis that might not be obvious on physical examination. These measures will determine if your patient should be considered for participation in the Targit Trial. They will also greatly improve the chances that her first operative will be successful, thus minimizing the need for addition breast or lymph node surgery.
9. Will my patient have the option of having
the lumpectomy first, then intraoperative radiotherapy in a separate procedure
after her pathology reports have been confirmed?
Although most patients who are chosen to receive Single-Day Intraoperative Radiotherapy will receive intraoperative radiotherapy at the time of their first operation, some patients might choose to receive and discuss their pathology results prior to receiving Single-Day Intraoperative Radiotherapy. This approach will prevent intraoperative radiotherapy from being given needlessly if the pathology results reveal that the tumor has not been adequately removed and that more surgery is needed. The USC Targit Trial protocol permits intraoperative radiotherapy to be given only once. Therefore, a woman who receives intraoperative radiotherapy during the first operation who then undergoes a second operation to the same breast will not be given intraoperative radiotherapy a second time. Instead, after recovering from surgery, she will need to undergo Conventional Postoperative Radiotherapy.
In addition, for individual patients with tumors of unclear size, or for those with questionably involved lymph nodes, the surgeon and radiation oncologist might advice her to undergo surgery first, following the Intraoperative Radiotherapy at a later date, if they are concerned that the final pathology results will not permit her to receiving Intraoperative Radiotherapy as the sole radiotherapy treatment, for example, if her final tumor size is more than 3cm, or if her final sentinel node results show metastatic carcinoma. To ensure that you patient is a good candidate for the Targit Trial, the surgeon and radiation oncologist will use a range of studies to understand the nature and dimensions of cancer within your patients breast. Ideally, this will include breast MRI to define the tumor dimensions and to rule out multifocal, multicentric, or bilateral breast cancer. If will also include axillary lymph node ultrasound to detect lymph node metastasis that might not be obvious on physical examination. These measures will determine if your patient should be considered for participation in the Targit Trial. They will also greatly improve the chances that her first operative will be successful, thus minimizing the need for addition breast or lymph node surgery.
10. What are the advantages of Single-Day
Targeted Intraoperative Radiotherapy?
The principal advantage of Single-Day Targeted Intraoperative Radiotherapy is the ability to administer the entire therapeutic dose of breast radiotherapy at the time of surgery while your patient is still under anesthesia. This allows her to complete cancer therapy sooner, permitting a quicker return to her normal life. For patients who do not need chemotherapy, this means that almost their entire breast cancer therapy can be completed in a single day. Daily oral endocrine therapy would be the only treatment remaining.
Another benefit of Single-Day Targeted Intraoperative Radiotherapy is the ability of the surgeon and radiation oncologist to target the radiotherapy treatment to the part of the breast at greatest risk of a breast cancer recurrence. This avoids the possibility of a “geographical miss” that sometimes occurs with Conventional Postoperative Radiotherapy. Because of the potential for “geographical miss”, the radiation oncologist normally requests that your patient obtain several pre-treatment radiological studies (for example, a CT scan) so that she can properly plan your treatment. Since Targeted Intraoperative Radiotherapy is given directed into the lumpectomy cavity, this treatment completely avoids the possibility of geographical miss. Focusing the radiotherapy treatment to the breast tissues immediately surrounding the lumpectomy cavity has the additional benefit if sparing nearby normal tissues (breast, skin, chest wall and shoulder) of the effects of radiation.
11. What are the disadvantages of Single-Day
Targeted Intraoperative Radiotherapy?
The principal disadvantage of Single-Day Targeted Intraoperative Radiotherapy
is that this treatment is still under investigation as an alternative
to Conventional Postoperative Radiotherapy. Although the risk of breast
cancer recurrence within the first 5 years after treatment appears to
be equally low for Single-Day Targeted Intraoperative Radiotherapy and
Conventional Postoperative Radiotherapy, more research is needed to determine
if the breast cancer recurrence rate will remain low in the Single-Day
Targeted Intraoperative Radiotherapy group.
Since Single-Day Targeted Intraoperative Radiotherapy treats only a portion of the breast, a disadvantage of this treatment is the potential for an increased chance of breast cancer recurrence in the portions of the breast that are not treated with radiotherapy. To minimize the chances of a breast cancer recurrence, the Targit Trial will only enroll women who have well-define, completely removed, breast cancers that have a relatively low risk of local recurrence.
Another disadvantage of Single-Day Targeted Intraoperative Radiotherapy
is that the radiotherapy treatment is given at the time of surgery, before
the final results of your pathology are known. If the pathology results
indicate that your patient will need additional breast surgery, she will
not be permitted to receive Targeted Intraoperative Radiotherapy again.
Therefore, she will have to receive Conventional Postoperative Radiotherapy
after recovering from surgery. To ensure that you patient is a good candidate
for the Targit Trial, the surgeon and radiation oncologist will use a
range of studies to understand the nature and dimensions of cancer within
your patients breast. Ideally, this will include breast MRI to define
the tumor dimensions and to rule out multifocal, multicentric, or bilateral
breast cancer. If will also include axillary lymph node ultrasound to
detect lymph node metastasis that might not be obvious on physical examination.
These measures will determine if your patient should be considered for
participation in the Targit Trial. They will also greatly improve the
chances that her first operative will be successful, thus minimizing the
need for addition breast or lymph node surgery.
12. What are the possible side effects and
risks associated with participating in the Targit Trial?
Side Effects and Risks Related to Surgery: Side effects and risks related to breast cancer surgery are similar to any cancer removal surgery: infection, bleeding, loss or reduced nerve function, swelling (edema), blood clotting, hematoma (accumulation of blood within the wound), seroma (accumulation of fluid within the wound), wound breakdown, bruising, scarring, and allergic reactions. If severe, these complications may require admission to the hospital or possibly additional surgery. Your patient may also need to undergo additional breast surgery if her first operation does not adequately remove the cancer.
Side Effects and Risks Related to Conventional Postoperative Radiotherapy: Conventional Postoperative Radiotherapy may cause redness and soreness of the skin of the breast, tenderness or painful sensations within the breast, feeling sick (nausea) and tiredness. These side effects gradually disappear after the treatment has finished, but might also continue for several months. Complications arising from Conventional Postoperative Radiotherapy include infection, loss or impairment of nerve function, swelling (edema), scarring, rib fracture, chest wall pain, skin ulceration and radiation induced tissue death. Scarring may be a long-term complication of radiotherapy and some firmness, tenderness, pain or deformity in the treated area of the breast may develop in the future. Some of these treatments may limit the ability of physical examination and mammograms to evaluate the breast for a cancer recurrence and may require that you undergo additional studies to evaluate the breast.
Side Effects and Risks Related to Single-day Targeted Intraoperative Radiotherapy: Single-Day Targeted Intraoperative Radiotherapy may cause redness and soreness of the skin of the breast, tenderness or painful sensations within the breast, feeling sick (nausea) and tiredness. These side effects gradually disappear after treatment has finished, but may also continue for several months. Complications arising from Single-Day Targeted Intraoperative Radiotherapy include loss or impairment of nerve function, swelling (edema), scarring, chest wall pain, skin ulceration, radiation induced tissue death, and delayed wound healing. Scarring may be a long-term complication and some firmness, tenderness, pain or deformity in the treated area of the breast may develop in the future. Some of these treatments may limit the ability of physical examination and mammograms to evaluate the breast for a cancer recurrence and may require that your patient undergo additional studies to evaluate the breast. Since Single-day Targeted Intraoperative Radiotherapy is given to only a portion of the breast, there is a risk that the untreated portions of the breast will be at greater risk of developing a breast cancer recurrence. For your patient's protection, study investigators will make every reasonable effort to ensure that your patient is a good candidate for Single-day Targeted Intraoperative Radiotherapy.
Your patient might experience no side effects, some of them or most of
them. Although she will be closely monitored, not all side effects can
be predicted and unforeseen problems can arise. There may be some unknown
or unanticipated risks or discomforts in addition to those specified above.
Side Effects and Risks Related to Chemotherapy:
If chemotherapy is needed to treat your patient's cancer,
some patients undergoing chemotherapy after first receiving radiotherapy
may experience a skin reaction consisting of redness, blistering, or peeling
of the skin of the breast. These side effects are usually mild and usually
heal in a few weeks. Oral or topical medications are sometimes needed.
Since Single-Day Targeted Intraoperative Radiotherapy is given at the
time of surgery, before chemotherapy, a skin reaction may be associated
with this treatment.
Risk Related to Pathology: If your patient has received Single-Day Targeted Intraoperative Radiotherapy at the time of surgery, but is found after surgery to have a tumor greater than 3 centimeters (1-1/8 inches), extensive non-invasive cancer (DCIS), or cancer involving her lymph nodes, she will be advised to undergo Conventional Postoperative Radiotherapy in spite of having already received Single-Day Targeted Intraoperative Radiotherapy. If the pathology results reveal that the tumor has been inadequately excised, she will also be advised to undergo additional surgery prior to undergoing Conventional Postoperative Radiotherapy.
To ensure that you patient is a good candidate for the Targit Trial, the surgeon and radiation oncologist will use a range of studies to understand the nature and dimensions of cancer within your patients breast. Ideally, this will include breast MRI to define the tumor dimensions and to rule out multifocal, multicentric, or bilateral breast cancer. If will also include axillary lymph node ultrasound to detect lymph node metastasis that might not be obvious on physical examination. These measures will determine if your patient should be considered for participation in the Targit Trial. They will also greatly improve the chances that her first operative will be successful, thus minimizing the need for addition breast or lymph node surgery.
Risk of Breast Cancer Recurrence: Regardless of the type of radiotherapy your patient receives, there is a risk that cancer might recur in her breast. Since Single-Day Targeted Intraoperative Radiotherapy treats only a portion of the breast, theoretically, there is a increased chance of breast cancer recurrence in the portions of the breast that are not treated with radiotherapy. Although the risk of breast cancer recurrence within the first 5 years after treatment appears to be equally low for Single-Day Targeted Intraoperative Radiotherapy and Conventional Postoperative Radiotherapy, more research is needed to determine if the breast cancer recurrence rate will remain similar between the two treatments. To minimize the chances of a breast cancer recurrence, the Targit Trial will only enroll women who have a low risk of breast cancer recurrence.
13. Can my patient participate in the Targit
Trial if she will need to receive chemotherapy or hormonal therapy?
Most women with breast cancer are advised to take chemotherapy or endocrine treatment to try to reduce the chance of cancer recurrrence and to improve long-term survival. Participation in the Targit Trial will not prevent your patient from receiving these treatments, nor will it interfere with the type, timing, or dosage of these treatments. If your patient has been assigned to receive Intraoperative Radiotherapy and has also been advised to receive chemotherapy, her chemotherapy treatment may be started as soon as her medical oncologist is ready to treat her. If she has been assigned to receive Conventional Postoperative Radiotherapy, chemotherapy may be started soon after she has recovered from surgery, and then will be followed by Conventional Postoperative Radiotherapy after she has completed chemotherapy. Finally, if she has been advised to receive endocrine therapy (for example, Tamoxifen or Arimidex), this treatment is usually started after she has completed all chemotherapy and radiotherapy.
14. When will the results of the Targit Trial be known?
The results of the Targit Trial may not be analyzed for several years, following strict scientific guidelines as to when this should be done. Until then, the data from the study will be regularly reviewed by a small group of international experts not directly involved in the study (called the Data Monitoring and Safety Committee). They will advise and make recommendations on the safety and conduct of the study. They are independent and ensure that the study is run to the highest ethical and scientific standards.
When the results have been analyzed, the results will be shared with you and your patient. A paper will also be published in a scientific journal so that doctors all over the world can read the results. Individual patients will not be identifiable from the information in any publication.
15. Will your patient's medical information be kept private?
Every effort will be made by the investigators to maintain the confidentiality of your patient's medical records. However, we cannot guarantee absolute confidentiality. Your patient's personal information may be disclosed if required by law. Specific study-related information will be made available to Zeiss, Inc., the manufacturer of the Intraoperative Radiotherapy equipment. For safety reasons, the Food and Drug Administration (FDA) will be allowed access to your patient's medical records. Unless required by law, the FDA will maintain the confidentiality of her medical records. If results of this study are published in medical literature, your patient will not be identified by name. With your patient's permission, medical information will be provided to her insurance company or to Medicare.
16.What are the costs of participating in
the Targit Trial?
After your patient have been assigned to one of the two treatments, USC will contact your patient's insurance company or Medicare to determine if it will pay for her treatments. If the insurance company or Medicare refuses to pay for the treatments, she may only participate in the Targit Trial if she is willing and able to pay for the treatments herself. USC will inform her of all associated costs prior to making a final decision to participate in the Targit Trial. The doctors are willing to help your patient obtain payment authorization from her insurance company or Medicare. There is no patient compensation for participating in the Targit Trial.
17. What are my patient's rights as a participant
in the Targit Trial?
Participation in the Targit Trial is voluntary. Your patient's decision whether or not to take part will not affect her current or future care at USC. Participation does not require waiving of any legal claims or rights. If your patient does decide to take part in this study, she is free to change your mind and stop being in the study at any time.
18. Who do I call if I have a question about
or problems related to the Targit Trial?
If you have any questions about or problems related to the Targit Trial, you should contact the Principal Investigator, Dr. Dennis Holmes, at 323-865-3933 or targittrial@surgery.usc.edu. If you or your patient have any questions about her rights as a study participant, you or she may contact the Institutional Review Board Office at LAC+USC Medical Center, IRD Building, 2020 Zonal Ave., Suite 425, Los Angeles, CA 90033 (Telephone number: 323-223-2340). You may also receive a copy of the Informed Consent statement, download or request a copy of the Targit Trial Patient DVD, or view or request a Targit Trial Patient Brochure.
