RecruitingPhase 4NCT06072807

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

Brain [18F]-FES PET/CT in the Diagnosis, Treatment Planning and Response Assessment of Brain Metastases in Patients With Estrogen-Receptor Positive Breast Cancer


Sponsor

Weill Medical College of Cornell University

Enrollment

20 participants

Start Date

Dec 27, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria7

  • 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 Criteria3

  • Pregnancy
  • Unable to undergo Standard of Care
  • Allergy to FES.

Interventions

DIAGNOSTIC_TESTBrain Imaging with 18F-FES

Using 18F-FES radiotracer in PET/CT scan to evaluate brain metastases in ER positive breast cancer patients.


Locations(1)

New York-Presbyterian/Weill Cornell Medical Center

New York, New York, United States

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NCT06072807


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