Status:
RECRUITING
Brain [18F]-FES PET/CT in Patients With Estrogen-Receptor Positive Breast Cancer
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
GE Healthcare
Conditions:
Breast Cancer
Brain Metastases
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
The goal of this interventional study is to optimize the protocol of FES PET/CT in Estrogen Receptor positive Breast cancer patients with Brain metastases. Patients will undergo MRI of the brain and F...
Detailed Description
Objectives 1. Evaluate the kinetics of dynamic brain FES PET/CT and optimize acquisition protocol. 2. Evaluate utility of FES PET/CT as an adjunct modality in radiotherapy planning. 3. (Exploratory a...
Eligibility Criteria
Inclusion
- Active diagnosis of ER+ breast cancer (biopsy proven) and new or recurrent brain metastases (biopsy proven or suspected based on MRI appearance)
- Ability to provide informed consent
- Discontinuation of ER modulators for at least 8 weeks, and discontinuation of ER down regulators for at least 28 weeks (as per manufacturer guidelines)
- Age \>=18 years
- Eastern Cooperative Oncology Group performance score 0-1
- Life expectancy \>=6 months
- Planned for radiation treatment for brain metastases
Exclusion
- Pregnancy
- Unable to undergo Standard of Care
- Allergy to FES.
Key Trial Info
Start Date :
December 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06072807
Start Date
December 27 2023
End Date
December 1 2027
Last Update
November 24 2025
Active Locations (1)
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1
New York-Presbyterian/Weill Cornell Medical Center
New York, New York, United States, 10021