Pilot Study of Zirconium-89 Bevacizumab Positron Emission Tomography for Imaging Angiogenesis in Patients With Inflammatory Breast Carcinoma Receiving Preoperative Chemotherapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01894451|
Recruitment Status : Active, not recruiting
First Posted : July 10, 2013
Last Update Posted : February 7, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Breast Carcinoma||Drug: 89Zr-bevacizumab Procedure: FDG-PET/CT Procedure: MRI scan Procedure: Tumor biopsies||Early Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Zirconium-89 Bevacizumab Positron Emission Tomography for Imaging Angiogenesis in Patients With Inflammatory Breast Carcinoma Receiving Preoperative Chemotherapy|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2020|
U.S. FDA Resources
Experimental: 89Zr-bevacizumab-PET/CT Scan
Participants will be injected with 1 mCi of 89Zr-bevacizumab intravenously and PET/CT images will be obtained at 3-4 days after 89Zr-bevacizumab administration to allow time for antibody accumulation in the tumor. Imaging will be performed on a Centers for Quantitative Imaging Excellence (CQIE) qualified PET/CT scanner at the Dana-Farber Cancer Institute. After the baseline scan, subsequent scans will be obtained on the same PET/CT scanner for an individual participant.
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). 89Zr-bevacizumab-PET/CT will be performed in this study at baseline, after 2 cycles of preoperative chemotherapy and at the completion of chemotherapy.Procedure: FDG-PET/CT
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.Procedure: MRI scan
• 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.Procedure: Tumor biopsies
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.
- Quality Control Standards for Radiopharmamceuticals and Number of Successfully Acquired 89Zr-bevacizumab-PET/CT scans [ Time Frame: 2 years ]In order to determine if 89Zr-bevacizumab-PET/CT scanning is feasible, we will determine results of radiolabeling of chelated bevacizumab including the radiolabeling yield, specific activity, and radiochemical purity and the number of successfully acquired 89Zr-bevacizumab-PET/CT scans.
- Number of related adverse events after the intravenous administration of 89Zr-bevacizumab. [ Time Frame: 2 years ]To determine the safety of 89Zr-bevacizumab-PET/CT imaging in patients with IBC, the number of adverse events related to the radiotracer (89Zr-bevacizumab) will be determined.
- Biodistribution of 89Zr-bevacizumab and individual organ and effective dose of 89Zr-bevacizumab [ Time Frame: 2 Years ]
- Amount of 89Zr-bevacizumab uptake in IBC tumor and measures of tumor angiogenesis in research biopsy specimens. [ Time Frame: 2 Years ]The amount of 89Zr-bevacizumab uptake in IBC tumor will be primarily given by standardized uptake values from PET/CT imaging. Measures of tumor angiogenesis are intratumoral microvessel density (MVD), vessel diameter, and vascular pericyte coverage
- Changes in tumor uptake of 89Zr-bevacizumab and FDG during and after preoperative chemotherapy and response in primary IBC tumor MRI. [ Time Frame: 2 Years ]This outcome aims to determine if 89Zr-bevacizumab provides similar results in regards to monitoring therapy response compared to standard modalities, FDG-PET/CT and MRI breast
- To correlate the changes in tumor uptake on 89Zr-bevacizumab-PET/CT with standard imaging response using MRI and FDG-PET/CT [ Time Frame: 2 Years ]
- Visualization of primary IBC tumor and visualization and number of distant metastases [ Time Frame: 2 years ]This is an exploratory outcome measure to see if 89Zr-bevacizumab detects primary and metastatic IBC tumor in a similar fashion
- Percent change in 89Zr-bevacizumab tumor uptake in primary IBC tumor between the baseline and post preoperative chemotherapy PET/CT scans and residual cancer burden at mastectomy/tissue sampling if residual disease [ Time Frame: 2 years ]This outcome measure is exploratory to investigate whether changes in tumor uptake of 89Zr-bevacizumab can predict response in mastectomy specimens.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01894451
|United States, Massachusetts|
|Brigham and Womens Hospital|
|Boston, Massachusetts, United States, 02215|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Heather A Jacene, MD||Dana-Farber Cancer Institute|