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

RECRUITINGPhase 4Sponsored by Weill Medical College of Cornell University
Actively Recruiting
PhasePhase 4
SponsorWeill Medical College of Cornell University
Started2023-12-27
Est. completion2027-12
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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.

Conditions3

Brain MetastasesBreast CancerCancer

Locations1 site

New York-Presbyterian/Weill Cornell Medical Center
New York, New York, 10021
Jana Ivanidze, MD/PhD212-746-4587jai9018@med.cornell.edu

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