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Purpose of Study

Consent for Research Study Contrast-Enhanced Breast MRI and MRS: A Correlative Science Studies to Characterize Tumor Response in Patients Undergoing Neoadjuvant Treatment for Locally Advanced Breast Cancer.

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Purpose of Study

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  1. Consent for Research StudyContrast-Enhanced Breast MRI and MRS:A Correlative Science Studies to Characterize Tumor Response in Patients Undergoing Neoadjuvant Treatment for Locally Advanced Breast Cancer This research is a collaborative effort between two National Cancer Institute (NCI) cooperative groups: Cancer and Leukemia Group B (CALGB) and the American College of Radiology Imaging Network (ACRIN). CALGB is recruiting participants for the neoadjuvant treatment trial and inviting those participants to also take part in the ACRIN imaging trial.

  2. The main goals of this research study are: 1. To determine whether we can predict how women will respond to certain chemotherapy treatments. This will be done by: Looking for particular molecules within the breast cancer cells and blood samples Determining the properties of the breast cancer cells through use of MRI (magnetic resonance imaging) and MRS (magnetic resonance spectroscopy) Observing the arrangement of the breast cancer cells within the breast Purpose of Study

  3. 2. To determine if MRI/MRS scans can be routinely used to monitor the shrinkage of breast tumors in women receiving chemotherapy prior to breast surgery. Purpose of Study (cont.) • Approximately 384 women will participate in this clinical trial.

  4. You will be in this study during the entire time you are receiving treatment We will check with your doctor every 6 months for approximately 10 years after treatment is completed Your participation is voluntary and you may stop at any time Participation Requirements

  5. Your doctor may also decide to stop your participation in this study if: It benefits you medically Funding has stopped Your condition worsens New information becomes available Participation Requirements cont.

  6. MRI/MRS scans Four (4) will be performed during the study: Scan 1 - before you begin type 1 chemotherapy treatment Scan 2 - after you begin the first cycle of type 1 chemotherapy treatment Scan 3 - at the completion of all chemotherapy treatments and before surgery is performed Scan 4 (optional) - either before or after type 1 chemotherapy treatment Study Procedures

  7. Biopsy (core needle*) and Tissue Sample A core needle biopsy will be done before you start type 1 chemotherapy A second, optional core needle biopsy will be done at the beginning of type 2 chemotherapy A biopsy will also be performed at the time of surgery * a core needle biopsy is a procedure in which your doctor inserts a needle into your breast to extract a small piece of tissue Study Procedures cont.

  8. Mammograms Two (2) will be performed: The first mammogram will be performed before you start type 1 chemotherapy The second will be done after you complete all chemotherapy treatments and before surgery Blood Samples Blood will be collected at two different time points, both before and after type 1 chemotherapy treatment Standard Medical Procedures

  9. Ultrasound Your doctor will determine whether you will have two (2) ultrasounds done before and after all chemotherapy treatments Standard Medical Procedures cont.

  10. If you agree to take part in this study, you and your doctor have decided to treat your breast cancer with chemotherapy prior to surgery You will receive standard chemotherapy that includes: anthracycline (type 1) and taxane (type 2) chemotherapy drugs If you chose not to participate, the care you receive will not be affected Treatment Options

  11. Patient _______________ Neoadjuvant MRI Correlative Science Trial Procedure Time Line Date _________ Date _________ Date _________ Date _________ Date _________ Date _________ Date _________ 1-3 days after Start of AC Cycle 1 6A SURGERY Date _________ Mammogram Optional MRI/ MRS Serum sample #1 Serum sample #2 MRI/ MRS #3 MRI/ MRS #1 MRI/ MRS #2 Mammogram Core Biopsy #1 O.R. Tissue Specimens 1 2 3 4 5 Cycle 4 Cycle 2 Cycle 3 Cycle 1 Start AC End AC Date _________ Date _________ Date _________ Date _________ Advocate Call If Starting TAXANE see page 2 AC Chemo dates

  12. Cycle 2 Cycle 4 Cycle 1 Patient _______________ Neoadjuvant MRI Correlative Science Trial Page 2, Taxane arm Date _________ Date _________ Date _________ Date _________ Optional Core Biopsy Optional MRI/ MRS Serum sample #2 Mammogram MRI/ MRS #3 SURGERY Date _________ 8T 9T 6T 7T Cycle 3 Advocate Call O.R. Tissue Specimens Date _________ Date _________ Date _________ Date _________ Taxane Chemo dates

  13. If you chose to participate in this study you are at risk of side effects. Your doctor or research associate will discuss these with you in more detail The risk of side effect is associated with the following procedures: MRI and MRS scans Contrast agent (Gadolinium) Intravenous catheter placement Biopsies If you are pregnant or plan to become pregnant you should not participate in this study due to reproductive risks Risks Associated with Study Participation

  14. While this study may or may not be of direct medical benefit to you, your participation could: Help determine, at a very early stage, whether patients are having a positive/negative response to treatment Allow doctors to tailor treatments to specific patients Give doctors the ability to stop treatment and avoid the side effects or after effects that a patient would normally incur Benefits of Participation

  15. Every effort will be made to keep your personal information confidential Confidential copies of your records will be stored in the following locations while you are on the study: The participating institution American College of Radiology (ACRIN) Center for Statistical Sciences at Brown University Cancer and Leukemia Group B (CALGB) Statistical Center at Duke University Organizations such as CALGB, Food and Drug Administration (FDA) and National Cancer Institute (NCI) may inspect or copy your records for quality assurance and data analysis Patient Confidentiality

  16. There is no additional cost to the patient for participation in this study Please speak with your doctor or research associate about specific details regarding reimbursement, any added costs or insurance problems Cost of Participation

  17. Regarding the research 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) If you have questions…

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