Consent for Research Study A study for patients diagnosed with locally advanced breast cancer Learning if the imaging agent, [ 18 F] fluorothymidine (FLT), helps to predict the success chemotherapy treatment A research study coordinated by the American College of Radiology Imaging Network (ACRIN)

Purpose of the Study This research study is being done to evaluate the imaging agent [ 18 F] fluorothymidine, often referred to as “FLT”. The study doctors want to know if FLT is helpful for predicting how well chemotherapy shrinks breast cancer tumor. 54 participants will be involved in this study

Participation Requirements Your direct participation will consist of: A screening visit Three FLT-PET imaging sessions Just before you start chemotherapy treatments One week after you start chemotherapy treatments After chemotherapy treatments have been completed

Participation Requirements Research studies will be done on the tissue removed during your surgery after you complete your chemotherapy treatments. Your participation is voluntary, you may stop at any time

Participation Requirements Your participation in this study may be stopped at any time by the study doctor or the sponsor without your consent. The reasons might include: –The study doctor thinks it necessary for your health or safety; –You have not followed study instructions; –The sponsor has stopped the study; –Administrative reasons require your withdrawal

About FLT FLT is used to help image the growth of tumor cells and may be used to show how well chemotherapy is working FLT is an investigational imaging agent, which means that it has not been approved by the U. S. Food and Drug Administration (FDA) It is hoped that FLT-PET imaging done before and during chemotherapy will show whether your tumor is staying the same, growing, or shrinking

Study Procedures Screening Visit – this will take place within 4 weeks before beginning the first imaging session to determine whether you meet the study entrance requirements. Also: –A medical history will be taken –You will have a physical exam, and your vital signs (temperature, blood pressure, heart rate and blood oxygen level) may be recorded. Some of this information may be taken from your medical records –Blood will be drawn to test your blood chemistry and liver function –If some of these tests have been done previously and the results are available in your medical records, they will not be repeated

Study Procedures FLT-PET Scans - There will be three imaging sessions –For each scan, you: Will receive an IV injection of FLT through an IV. Will remain still for about an hour and a half while images of your chest and then your whole body are taken About 35 minutes later, (two hours after the injection) you will return to the PET scanner for a second whole body image, which will take about 30 minutes

Study Procedures Tumor tissue collection During your surgery, which is part of standard care, any remaining tumor will be removed. This tissue will be tested for tumor growth and to help identify tumor staging. All your personal information will be removed from the sample.

Risks of Participation FLT is NOT an FDA approved drug There are no known side effects from earlier studies using FLT. As with all medications, there is a risk of allergic reaction

Benefits of Participation This is not a treatment study and you are not expected to receive any direct medical benefits from your participation. The information learned from this study may lead to better treatment in the future for patients with breast cancer

Patient Confidentiality Every effort will be made to keep your personal information confidential. Confidential copies of your records during your participation will be kept at the participating hospital or medical center. All participant research information sent to ACRIN headquarters in Philadelphia, PA will be coded so that study participants cannot be identified.

Patient Confidentiality cont. Organizations such as the following may inspect or copy your records at the participating hospital or medical center for quality assurance and data analysis: ACRIN Food and Drug Administration (FDA) National Cancer Institute (NCI) Institutional Review Board (IRB)

Costs and Payment Taking part in this study will not lead to added costs to you or your insurance company While ACRIN does not pay for participation in studies, reasonable travel expenses will be reimbursed: –$180 for completion of all 4 scans –$45 for each completed scan if all 4 were not completed

Participation Rights Taking part in this study is voluntary You may choose not to take part or leave the study at any time. Leaving the study will not result in any penalty or loss of benefits Participation in this study may delay treatment by up to 1 week If you leave the study before the final visit, you may be asked by the study doctor to make a final visit for some of the end of study procedures

If you have questions: Regarding the study: –Contact the study doctor or research associate Regarding patients’ rights: –Ask your study doctor or research associate who you should contact at their Institutional Review Board (IRB) Regarding general cancer research: –National Cancer Institute: CANCERwww.cancer.gov –American Cancer Society: ACS 2345www.cancer.org