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Recruiting Phase 4 NCT06072807

Brain [18F]-FES PET/CT in Patients With Estrogen-Receptor Positive Breast Cancer

Trial Parameters

Condition Breast Cancer
Sponsor Weill Medical College of Cornell University
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 20
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2023-12-27
Completion 2027-12
Interventions
Brain Imaging with 18F-FES

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 FDG PET/CT brain as part of standard of care for radiation treatment planning. An additional 18F-FES PET/CT brain scan will be completed before this standard of care radiation treatment. Patients will be followed prospectively with clinical and MRI assessments per standard-of-care for a total of 12 months. Study Population: Patients with ER-positive breast cancer with biopsy proven or suspected new or recurrent brain metastases (based on standard of care MRI) planned for radiation treatment of brain lesions.

Eligibility Criteria

Inclusion Criteria: 1. Active diagnosis of ER+ breast cancer (biopsy proven) and new or recurrent brain metastases (biopsy proven or suspected based on MRI appearance) 2. Ability to provide informed consent 3. Discontinuation of ER modulators for at least 8 weeks, and discontinuation of ER down regulators for at least 28 weeks (as per manufacturer guidelines) 4. Age \>=18 years 5. Eastern Cooperative Oncology Group performance score 0-1 6. Life expectancy \>=6 months 7. Planned for radiation treatment for brain metastases Exclusion Criteria: 1. Pregnancy 2. Unable to undergo Standard of Care 3. Allergy to FES.

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