Clinical Trial · NCT06072807

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

Overview

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.

Sponsor

Weill Medical College of Cornell University

Phase

Phase 4

Contacts

Alexis Watson (CONTACT)

alw4020@med.cornell.edu

646-962-2347

Jana Ivanidze, MD/PhD (CONTACT)

jai9018@med.cornell.edu

212-746-4587

Jana Ivanidze, MD/PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT06072807

Drug / Compound

FES

Isotope(s):

Target(s):

Estrogen Receptor

Ligand Class: Small Molecules

FDG

Isotope(s):

Target(s):

Glucose Transport

Ligand Class: Small Molecules

Eligibility

Inclusion

Planned for radiation treatment for brain metastases
Active diagnosis of ER+ breast cancer (biopsy proven) and new or recurrent brain metastases (biopsy proven or suspected based on MRI appearance)
Eastern Cooperative Oncology Group performance score 0-1
Discontinuation of ER modulators for at least 8 weeks, and discontinuation of ER down regulators for at least 28 weeks (as per manufacturer guidelines)
Life expectancy \>=6 months

Exclusion

Pregnancy
Unable to undergo Standard of Care
Allergy to FES.