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About
This research study is a pilot study, which tests the ability of an investigational compound to be used in humans for further studies. "Investigational" means that 89Zr-bevacizumab for PET/CT imaging is being studied. It also means that the FDA (U.S. Food and Drug Administration) has not approved 89Zr-bevacizumab for PET/CT imaging for use in patients, including people with your type of cancer.
89Zr-bevacizumab is a newly developed radiotracer. Radiotracers are compounds or drugs that are attached to small amounts of a radioactive substance. The amount of the compound or drug in a radiotracer is also very small. Radiotracers are used to make images of processes that are happening in the body, but they do not affect how the body works. 89Zr-bevacizumab is made up of the drug bevacizumab and the radioactive substance zirconium-89 (89Zr). 89Zr-bevacizumab is used for an imaging procedure called positron emission tomography/computed tomography (PET/CT). This radiotracer has been used in other research studies. Information from those other research studies suggests that 89Zr-bevacizumab-PET/CT imaging may be able to measure new blood vessel formation to determine where the cancer is in your body and if your cancer is being killed by chemotherapy.
Full description
Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated.
If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in this research study.
After the screening procedures confirm that you are eligible to participate in the research study:
Your primary oncologist will decide what chemotherapy you receive.
Before beginning preoperative chemotherapy (baseline):
Before beginning chemotherapy, you will undergo tests or procedures for the research study. Some of these tests and procedures are part of regular cancer care and some are being performed as part of the research study only.
After 2 cycles of preoperative chemotherapy: Two to five days prior to starting your third cycle of chemotherapy, study tests and procedures will be performed. Some of these tests and procedures are part of regular cancer care and some are being performed as part of the research study only.
After the completion of preoperative chemotherapy: Within 1-2 weeks after completing preoperative chemotherapy, study tests and procedures will be repeated to determine how well your cancer responded to the treatment. Some of these tests and procedures are part of regular cancer care and some are being performed as part of the research study only.
Surgery: After completing preoperative chemotherapy, your primary oncologist and surgeon will determine if you are eligible to undergo breast surgery. Breast surgery is part of regular cancer care. During your surgery, tissue from your tumor will be removed and tested for how well your cancer responded to treatment. This is part of regular cancer care. If there is enough tissue available after the tissue has been tested for how well your tumor responded to treatment, some tissue will be taken for research. If you are not able to undergo breast surgery, then you will have a tumor biopsy similar to before starting and after 2 cycles of chemotherapy.
Enrollment
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Inclusion criteria
Participants must meet the following criteria on screening examination to be eligible to participate in the study:
Exclusion criteria
Although bevacizumab will be administered in tracer quantities in this study and is not expected to have pharmacologic effects, participants with major surgery or significant bleeding episodes within 28 days before study initiation may be at a higher risk of bleeding.
Contraindications for MRI with contrast or PET/CT including:
Primary purpose
Allocation
Interventional model
Masking
2 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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