Back to resultsF18 EF5 PET/CT Imaging in Patients With Brain Metastases From Breast Cancer
Primary Purpose
Brain Metastases From Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PET/CT Imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Brain Metastases From Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Subjects with measurable brain metastases of at least 1 cm in any plane based on anatomic imaging.
- Subjects with prior resection of brain metastases with progressions on brain MRI.
- Histologic confirmation of breast cancer.
- Age of study subject must be > 18 years.
- ECOG Performance Status ≤ 2.
- Ability to undergo brain MR and PET imaging
- Study subjects must have normal organ and marrow function as defined below:
WBC >2,000/mmᶟ, platelets >90,000/mmᶟ, total bilirubin <2.0 mg/dl, creatinine <2.0 mg/dl.
- The effects of EF5 on the developing human fetus are unknown. For this reason, women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation (1 month). Should a woman become pregnant pr suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Women of childbearing potential will have a urine pregnancy test the day of the F18 -EF5 PET scan prior to the F18 -EF5 injection.
- Ability to understand, participate and provide a documented signed informed consent.
- Subjects who are allergic to gadolinium will have MRI scans without gadolinium contrast.
Exclusion Criteria:
- History of allergic reactions attributed to Flagyl (metronidazole), which has a chemical structure similar to EF5.
- Pregnant women are excluded because EF5 has an unknown risk for adverse events in fetuses and nursing infants secondary the administration of EF5 to the mother. Breastfeeding should be discontinued if EF5 is administered to the mother.
- Subject has any other condition or personal circumstance that, in the judgement of the investigator, might interfere with the collection of complete good quality data.
- Subjects who are unable to provide informed consent.
- Patients with prior whole brain radiotherapy.
- Patients with moderate to severe renal failure, defined as estimated GFR less than 30 ml/Lmin 1.73m²
Sites / Locations
- Abramson Cancer Center of the University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EF5
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events
Secondary Outcome Measures
Full Information
NCT ID
NCT01985971
First Posted
November 11, 2013
Last Updated
January 27, 2020
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01985971
Brief Title
F18 EF5 PET/CT Imaging in Patients With Brain Metastases From Breast Cancer
Official Title
F18 EF5 PET/CT Imaging in Patients With Brain Metastases From Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 19, 2016 (Actual)
Study Completion Date
August 19, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To estimate the presence of hypoxia in individual lesions after radiotherapy in patients with brain metastases from breast cancer as identified by F18 EF5 PET/CT imaging.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases From Breast Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EF5
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
PET/CT Imaging
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Time Frame
2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with measurable brain metastases of at least 1 cm in any plane based on anatomic imaging.
Subjects with prior resection of brain metastases with progressions on brain MRI.
Histologic confirmation of breast cancer.
Age of study subject must be > 18 years.
ECOG Performance Status ≤ 2.
Ability to undergo brain MR and PET imaging
Study subjects must have normal organ and marrow function as defined below:
WBC >2,000/mmᶟ, platelets >90,000/mmᶟ, total bilirubin <2.0 mg/dl, creatinine <2.0 mg/dl.
The effects of EF5 on the developing human fetus are unknown. For this reason, women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation (1 month). Should a woman become pregnant pr suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Women of childbearing potential will have a urine pregnancy test the day of the F18 -EF5 PET scan prior to the F18 -EF5 injection.
Ability to understand, participate and provide a documented signed informed consent.
Subjects who are allergic to gadolinium will have MRI scans without gadolinium contrast.
Exclusion Criteria:
History of allergic reactions attributed to Flagyl (metronidazole), which has a chemical structure similar to EF5.
Pregnant women are excluded because EF5 has an unknown risk for adverse events in fetuses and nursing infants secondary the administration of EF5 to the mother. Breastfeeding should be discontinued if EF5 is administered to the mother.
Subject has any other condition or personal circumstance that, in the judgement of the investigator, might interfere with the collection of complete good quality data.
Subjects who are unable to provide informed consent.
Patients with prior whole brain radiotherapy.
Patients with moderate to severe renal failure, defined as estimated GFR less than 30 ml/Lmin 1.73m²
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lilie Lin, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
F18 EF5 PET/CT Imaging in Patients With Brain Metastases From Breast Cancer
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