Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-29 @ 12:49 AM
Study NCT ID:
NCT01894451
Status:
COMPLETED
Last Update Posted:
2019-12-12
First Post:
2013-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of Zirconium-89 Bevacizumab Positron Emission Tomography for Imaging Angiogenesis in Patients With Inflammatory Breast Carcinoma Receiving Preoperative Chemotherapy
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
Pilot Study of Zirconium-89 Bevacizumab Positron Emission Tomography for Imaging Angiogenesis in Patients With Inflammatory Breast Carcinoma Receiving Preoperative Chemotherapy
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed 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.
* A medical history, which includes questions about your health, current medications, and any allergies. This is part of regular cancer care.
* Physical exam, your doctor will examine your body, including measuring your height, weight, and vital signs (blood pressure, body temperature, pulse rate and breathing rate). This is part of regular cancer care.
* Blood tests (approximately 3 teaspoons) will be drawn for tests to check how well your organs are functioning. This is part of regular cancer care.
* Blood pregnancy test will be performed for women who can become pregnant. About 1 teaspoon of blood will be drawn for the blood pregnancy test. This is part of regular cancer care.
* Performance status, to see how you carry out your daily activities. This is done by talking with you. This is done as part of regular cancer care.
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.
* FDG-PET/CT scan: Pictures of your organs will be taken using a PET (Positron Emission Tomography) scanner. At the same time, a CT (computed tomography) scan will be performed. FDG, a radioactive substance similar to glucose (or sugar), will be injected into your vein using a needle prior to performing the PET/CT scan. After the injection, you will be asked to sit quietly for one hour to let the FDG absorb into the body. After this hour, you will be asked to lie flat on your back for up to 50 minutes while the PET and CT images are being taken. This FDG-PET/CT scan is part of regular cancer care. If you have had this test within 14 days of study enrollment, you may or may not have to have this test repeated.
* MRI Scan: MRI (Magnetic Resonance Imaging) scans of the breast will be taken. You will receive an injection of a dye before the MRI. You will be asked to lie flat on your back in the scanner for up to 30 minutes for pictures to be taken. This MRI scan is part of regular cancer care. If you have had this test within 14 days of study enrollment , you may or may not have to have this test repeated.
* 89Zr-bevacizumab-PET/CT Scan: More pictures of your organs will be taken using a PET (Positron Emission Tomography) scanner. At the same time, a CT (computed tomography) scan will be performed. 89Zr-bevacizumab will be injected into your vein using a needle. You will be observed for approximately 1 hour after the injection of 89Zr-bevacizumab. It takes 3 to 4 days for the 89Zr-bevacizumab to be absorbed into the body. Therefore, the research PET and research CT scans (89Zr-bevacizumab-PET/CT) will be performed 3 to 4 days after the 89Zr-bevacizumab is injected into your vein.
* This 89Zr-bevacizumab-PET/CT scan is part of research (in addition to the FDG-PET/CT scan) and is not part of regular cancer care.
* Vital signs, including heart rate, blood pressure, temperature, and respiratory rate, will be performed immediately before and then approximately 5, 30, and 60 minutes after injection of 89Zr-bevacizumab and just before 89Zr-bevacizumab-PET/CT imaging. This is part of research.
* Blood pregnancy test will be performed for women who can become pregnant. About 1 teaspoon of blood will be drawn for the blood pregnancy test. If your blood pregnancy test to determine if you could be in the study was done longer than 24 hours before the injection of 89Zr-bevacizumab, it will be repeated.
* Blood tests (approximately 3 teaspoons) will be drawn for tests to check how well your organs are functioning. This is part of regular cancer care.
* Tumor biopsies: Prior to starting your treatment, a radiologist will use breast MRI or ultrasound imaging to localize an area of your tumor in the breast for a research biopsy. The biopsy procedure is done in an outpatient setting using a done using a needle to obtain tissue. A local anesthetic will be given to minimize any pain; however, after the procedure you can expect some discomfort and possible bruising. This biopsy is part of research.
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.
* FDG-PET/CT scan: The procedure is the same as that is described above. This FDG-PET/CT scan is part of research.
* MRI Scan: The procedure is the same as that is described above. This MRI scan is part of research.
* 89Zr-bevacizumab-PET/CT Scan: The procedure is the same as that is described above. This 89Zr-bevacizumab-PET/CT scan is part of research.
* Vital signs, including heart rate, blood pressure, temperature, and respiratory rate, is the same as that is described above. This is part of research.
* Blood pregnancy test will be performed for women who can become pregnant. This test is the same as that is described above. This is part of research.
* Blood tests (approximately 3 teaspoons) will be drawn for tests to check how well your organs are functioning. This is part of regular cancer care.
* Tumor biopsies: The procedure is the same that is described above. This biopsy is part of research.
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.
* FDG-PET/CT scan: The procedure is the same as that is described above. This FDG-PET/CT scan is part of research.
* MRI Scan: The procedure is the same as that is described above. This MRI scan is part of regular cancer care.
* 89Zr-bevacizumab-PET/CT Scan: The procedure is the same as that is described above. This 89Zr-bevacizumab-PET/CT scan is part of research.
* Vital signs, including heart rate, blood pressure, temperature, and respiratory rate, is the same as that is described above. This is part of research.
* Blood pregnancy test will be performed for women who can become pregnant. This test is the same as that is described above. This is part of research.
* Blood tests (approximately 3 teaspoons) will be drawn for tests to check how well your organs are functioning. This is part of regular cancer care.
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.
* A medical history, which includes questions about your health, current medications, and any allergies. This is part of regular cancer care.
* Physical exam, your doctor will examine your body, including measuring your height, weight, and vital signs (blood pressure, body temperature, pulse rate and breathing rate). This is part of regular cancer care.
* Blood tests (approximately 3 teaspoons) will be drawn for tests to check how well your organs are functioning. This is part of regular cancer care.
* Blood pregnancy test will be performed for women who can become pregnant. About 1 teaspoon of blood will be drawn for the blood pregnancy test. This is part of regular cancer care.
* Performance status, to see how you carry out your daily activities. This is done by talking with you. This is done as part of regular cancer care.
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.
* FDG-PET/CT scan: Pictures of your organs will be taken using a PET (Positron Emission Tomography) scanner. At the same time, a CT (computed tomography) scan will be performed. FDG, a radioactive substance similar to glucose (or sugar), will be injected into your vein using a needle prior to performing the PET/CT scan. After the injection, you will be asked to sit quietly for one hour to let the FDG absorb into the body. After this hour, you will be asked to lie flat on your back for up to 50 minutes while the PET and CT images are being taken. This FDG-PET/CT scan is part of regular cancer care. If you have had this test within 14 days of study enrollment, you may or may not have to have this test repeated.
* MRI Scan: MRI (Magnetic Resonance Imaging) scans of the breast will be taken. You will receive an injection of a dye before the MRI. You will be asked to lie flat on your back in the scanner for up to 30 minutes for pictures to be taken. This MRI scan is part of regular cancer care. If you have had this test within 14 days of study enrollment , you may or may not have to have this test repeated.
* 89Zr-bevacizumab-PET/CT Scan: More pictures of your organs will be taken using a PET (Positron Emission Tomography) scanner. At the same time, a CT (computed tomography) scan will be performed. 89Zr-bevacizumab will be injected into your vein using a needle. You will be observed for approximately 1 hour after the injection of 89Zr-bevacizumab. It takes 3 to 4 days for the 89Zr-bevacizumab to be absorbed into the body. Therefore, the research PET and research CT scans (89Zr-bevacizumab-PET/CT) will be performed 3 to 4 days after the 89Zr-bevacizumab is injected into your vein.
* This 89Zr-bevacizumab-PET/CT scan is part of research (in addition to the FDG-PET/CT scan) and is not part of regular cancer care.
* Vital signs, including heart rate, blood pressure, temperature, and respiratory rate, will be performed immediately before and then approximately 5, 30, and 60 minutes after injection of 89Zr-bevacizumab and just before 89Zr-bevacizumab-PET/CT imaging. This is part of research.
* Blood pregnancy test will be performed for women who can become pregnant. About 1 teaspoon of blood will be drawn for the blood pregnancy test. If your blood pregnancy test to determine if you could be in the study was done longer than 24 hours before the injection of 89Zr-bevacizumab, it will be repeated.
* Blood tests (approximately 3 teaspoons) will be drawn for tests to check how well your organs are functioning. This is part of regular cancer care.
* Tumor biopsies: Prior to starting your treatment, a radiologist will use breast MRI or ultrasound imaging to localize an area of your tumor in the breast for a research biopsy. The biopsy procedure is done in an outpatient setting using a done using a needle to obtain tissue. A local anesthetic will be given to minimize any pain; however, after the procedure you can expect some discomfort and possible bruising. This biopsy is part of research.
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.
* FDG-PET/CT scan: The procedure is the same as that is described above. This FDG-PET/CT scan is part of research.
* MRI Scan: The procedure is the same as that is described above. This MRI scan is part of research.
* 89Zr-bevacizumab-PET/CT Scan: The procedure is the same as that is described above. This 89Zr-bevacizumab-PET/CT scan is part of research.
* Vital signs, including heart rate, blood pressure, temperature, and respiratory rate, is the same as that is described above. This is part of research.
* Blood pregnancy test will be performed for women who can become pregnant. This test is the same as that is described above. This is part of research.
* Blood tests (approximately 3 teaspoons) will be drawn for tests to check how well your organs are functioning. This is part of regular cancer care.
* Tumor biopsies: The procedure is the same that is described above. This biopsy is part of research.
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.
* FDG-PET/CT scan: The procedure is the same as that is described above. This FDG-PET/CT scan is part of research.
* MRI Scan: The procedure is the same as that is described above. This MRI scan is part of regular cancer care.
* 89Zr-bevacizumab-PET/CT Scan: The procedure is the same as that is described above. This 89Zr-bevacizumab-PET/CT scan is part of research.
* Vital signs, including heart rate, blood pressure, temperature, and respiratory rate, is the same as that is described above. This is part of research.
* Blood pregnancy test will be performed for women who can become pregnant. This test is the same as that is described above. This is part of research.
* Blood tests (approximately 3 teaspoons) will be drawn for tests to check how well your organs are functioning. This is part of regular cancer care.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: