Clinical Trial: Pilot Study of Zirconium-89 Bevacizumab Positron Emission Tomography for Imaging Angiogenesis in Patients With Inflammatory Breast Carcinoma Receiving Preoperative Chemotherapy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Pilot Study of Zirconium-89 Bevacizumab Positron Emission Tomography for Imaging Angiogenesis in Patients With Inflammatory Breast Carcinoma Receiving Preoperative Chemoth

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.


Detailed Summary:

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
Sponsor: Dana-Farber Cancer Institute

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Dana-Farber Cancer Institute

Dates:
Date Received: June 25, 2013
Date Started: June 2015
Date Completion: October 2018
Last Updated: August 1, 2016
Last Verified: August 2016