Brain [18F]-FES PET/CT in Patients With Estrogen-Receptor Positive Breast Cancer
Part of paid clinical trials in New York, New York.
- Sponsor
- Weill Medical College of Cornell University
- Study ID
- NCT06072807
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Brain Metastases
- Breast Cancer
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Brain Imaging with 18F-FES — DIAGNOSTIC_TESTUsing 18F-FES radiotracer in PET/CT scan to evaluate brain metastases in ER positive breast cancer patients.
Study Details
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.
Key Dates
- Start date
- Dec 27, 2023
- Status verified
- Nov 2025
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: ER Positive Breast Cancer Patients with Brain MetastasesA diagnostic intervention where this group will undergo an additional 18F- FES PET/CT scan in addition to their standard of care MRI and FDG PET/CT scan.
Primary Outcome Measure
Mean SUV [ Time Frame: 3 years ]
Central Contacts
- Jana Ivanidze, MD/PhD212-746-4587
- Alexis Watson646-962-2347
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| New York-Presbyterian/Weill Cornell Medical Center | New York | New York | 10021 | Jana Ivanidze, MD/PhD (PRINCIPAL_INVESTIGATOR) |
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