Inflammatory Breast CarcinomaEarly Phase 1NCT01894451
Pilot Study of Zirconium-89 Bevacizumab Positron Emission Tomography for Imaging Angiogenesis in Patients With Inflammatory Breast Carcinoma Receiving Preoperative Chemotherapy
A Early Phase 1 study testing 89Zr-bevacizumab, FDG-PET/CT and MRI scan in people with Inflammatory Breast Carcinoma, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Inflammatory Breast Carcinoma
- What is being tested?
- 89Zr-bevacizumab, FDG-PET/CT and MRI scan
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2015to 17 Mar 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- Participants must have histologically or cytologically confirmed HER2 negative invasive breast adenocarcinoma.
- Participants must have clinical characteristics consistent with IBC, characterized by a rapid onset of clinical findings exemplified as diffuse edema and erythema of the breast, often without a palpable mass.
- Age ≥ 21 years. Because no dosing or adverse event data are currently available on the use of 89Zr-bevacizumab in participants <21 years of age, children are excluded from this study but will be eligible for future pediatric trials.
- Any stage is eligible.
- Participants must be eligible for preoperative chemotherapy for IBC as determined by the treating physician.
Show all 11Show fewer
- The effects of 89Zr-bevacizumab on the developing human fetus are unknown. For this reason and because radiopharmaceuticals may be teratogenic, women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability and willingness to comply with the study procedures.
- Ability to understand and the willingness to sign a written informed consent document.
- Participants must be willing to have research biopsies at baseline and after 2 cycles of preoperative chemotherapy, and possibly at the completion of preoperative chemotherapy.
- ECOG performance status ≤ 2.
Who cannot join
- Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study:
- Pregnant women are excluded from this study because 89Zr-bevacizumab and 18F-FDG are radiopharmaceuticals with the potential for teratogenic effects. Because of the radiation exposure to a nursing infant from 89Zr-bevacizumab and 18F-FDG, women who are breastfeeding are also excluded from this study. In addition, bevacizumab may cause fetal harm based on animal studies (2).
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Major surgery or significant bleeding episodes within 28 days before study initiation. Major surgery does not include: breast or other biopsies obtained for diagnosis, placement of radio-opaque clip to localize a tumor or tumors for subsequent surgical resection, placement of central venous access, pretreatment lymph node sampling. Significant bleeding episodes are defined for the purpose of this study as hemoptysis or upper/lower gastrointestinal bleeding.
- 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:
Show all 15Show fewer
- Cardiac pacemaker, implanted cardiac defibrillator, pacing wires, internal electrodes
- Aneurysm clips
- Cochlear, otologic, or other ear implant
- Tissue expander
- Swan-Ganz or Thermo Dilution
- Moderate renal insufficiency (estimated GFR less than 60 mL/min/1.73 m2) to end stage renal disease (estimated GFR less than 15 mL/min/1.73 m2 or a serum creatinine more than 3 mg/dL), who are not on dialysis, and patients with renal failure on chronic dialysis
- Severe claustrophobia
- History of multiple or severe allergic reactions attributed to immunoglobulins or MRI contrast agents.
- Any past or current condition that in the opinion of the study investigators would confound the results of the study or pose additional risk to the patient by their participation in the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Womens Hospital
Boston, Massachusetts, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
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.
Read the 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.
- Conditions
- Inflammatory Breast Carcinoma
- Being tested
- 89Zr-bevacizumab, FDG-PET/CT, MRI scan, Tumor biopsies
- Keywords
- Inflammatory Breast Carcinoma, 89Zr-bevacizumab
- Medical subject headings
- Inflammatory Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-bevacizumabDrug
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.
FDG-PET/CTProcedure or surgery
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 scanProcedure or surgery
- 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.
Tumor biopsiesProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 89Zr-bevacizumab-PET/CT Scan | Experimental | * 89Zr-bevacizumab-PET/CT will be performed at baseline, after 2 cycles of preoperative chemotherapy, and at the completion of preoperative chemotherapy.
* The 89Zr-bevacizumab-PET/CT imaging procedure is detailed in Appendix A and is briefly described below.
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. Receives: Drug: 89Zr-bevacizumab; Procedure: FDG-PET/CT; Procedure: MRI scan; Procedure: Tumor biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality Control Standards for Radiopharmamceuticals and Number of Successfully Acquired 89Zr-bevacizumab-PET/CT scans
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.
Measured: 2 years
Secondary outcomes (5)
Number of related adverse events after the intravenous administration of 89Zr-bevacizumab.
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.
Measured: 2 years
Biodistribution of 89Zr-bevacizumab and individual organ and effective dose of 89Zr-bevacizumab
Measured: 2 Years
Amount of 89Zr-bevacizumab uptake in IBC tumor and measures of tumor angiogenesis in research biopsy specimens.
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
Measured: 2 Years
Changes in tumor uptake of 89Zr-bevacizumab and FDG during and after preoperative chemotherapy and response in primary IBC tumor MRI.
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
Measured: 2 Years
To correlate the changes in tumor uptake on 89Zr-bevacizumab-PET/CT with standard imaging response using MRI and FDG-PET/CT
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startJun 2015
- Primary completion17 Mar 2017
- Study completion17 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Heather A. Jacene, Dana-Farber Cancer Institute
- Investigators
- Heather A Jacene, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894451
- Sponsor's protocol ID
- 13-147
- Status last verified
- Dec 2019
- First submitted
- 25 Jun 2013
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Zirconium-89 Bevacizumab Positron Emission Tomography for Imaging Angiogenesis in Patients With Inflammatory Breast Carcinoma Receiving Preoperative Chemotherapy
- ClinicalTrials.gov ID
- NCT01894451
- Acronym / sponsor ID
- 13-147
- Conditions
- Inflammatory Breast Carcinoma
- Keywords
- Inflammatory Breast Carcinoma, 89Zr-bevacizumab
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2015 (actual)
- Primary completion
- 17 Mar 2017 (actual)
- Study completion
- 17 Mar 2017 (actual)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 89Zr-bevacizumab-PET/CT Scan | Experimental | Drug: 89Zr-bevacizumab, Procedure: FDG-PET/CT, Procedure: MRI scan, Procedure: Tumor biopsies* 89Zr-bevacizumab-PET/CT will be performed at baseline, after 2 cycles of preoperative chemotherapy, and at the completion of preoperative chemotherapy. * The 89Zr-bevacizumab-PET/CT imaging procedure is detailed in Appendix A and is briefly described below. 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- Participants must have histologically or cytologically confirmed HER2 negative invasive breast adenocarcinoma.
- Participants must have clinical characteristics consistent with IBC, characterized by a rapid onset of clinical findings exemplified as diffuse edema and erythema of the breast, often without a palpable mass.
- Age ≥ 21 years. Because no dosing or adverse event data are currently available on the use of 89Zr-bevacizumab in participants <21 years of age, children are excluded from this study but will be eligible for future pediatric trials.
- Any stage is eligible.
Key exclusion criteria (15 listed)
- Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study:
- Pregnant women are excluded from this study because 89Zr-bevacizumab and 18F-FDG are radiopharmaceuticals with the potential for teratogenic effects. Because of the radiation exposure to a nursing infant from 89Zr-bevacizumab and 18F-FDG, women who are breastfeeding are also excluded from this study. In addition, bevacizumab may cause fetal harm based on animal studies (2).
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Major surgery or significant bleeding episodes within 28 days before study initiation. Major surgery does not include: breast or other biopsies obtained for diagnosis, placement of radio-opaque clip to localize a tumor or tumors for subsequent surgical resection, placement of central venous access, pretreatment lymph node sampling. Significant bleeding episodes are defined for the purpose of this study as hemoptysis or upper/lower gastrointestinal bleeding.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 89Zr-bevacizumab89Zr-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. | Drug | 89Zr-bevacizumab-PET/CT Scan |
| FDG-PET/CTFDG-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 or surgery | 89Zr-bevacizumab-PET/CT Scan |
| 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 or surgery | 89Zr-bevacizumab-PET/CT Scan |
| Tumor biopsiesTumor 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. | Procedure or surgery | 89Zr-bevacizumab-PET/CT Scan |
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.
5 secondary outcomes
Number of related adverse events after the intravenous administration of 89Zr-bevacizumab.
Time frame: 2 years
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
Related trials for Inflammatory Breast Carcinoma
Active, not recruitingPhase 2
Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Locally Advanced or Inflammatory Triple Negative Breast Cancer
Inflammatory Breast Cancer, Stage IIA Breast Cancer
Recruiting
Effects of SPSIP Block on Perioperative Inflammation and TLR4 in Breast Cancer Surgery
Serratus Posterior Superior Intercostal Plane Block (SPSIPB), Breast Cancer
Not yet recruiting
Feasibility and Effectiveness of Sentinel Lymph Node Biopsy in Inflammatory Breast Cancer
Breast Cancer
RecruitingPhase 2
TRUDI: TDXD+Durva in HER2+/Low IBC
Invasive Breast Cancer, Inflammatory Breast Cancer Stage III
RecruitingObservational study
Biospecimen and Medical Data Collection and Tumor Biopsy in Creating Research Tissue Registry in Patients With Inflammatory or Invasive Breast Cancer
Inflammatory Breast Carcinoma, Invasive Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather A Jacene, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 89Zr-bevacizumab, FDG-PET/CT and MRI scan in people with Inflammatory Breast Carcinoma, run by Dana-Farber Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality Control Standards for Radiopharmamceuticals and Number of Successfully Acquired 89Zr-bevacizumab-PET/CT scans (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.