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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
New York-Presbyterian/Weill Cornell Medical Center
RECRUITING
New York
Contact Information
Primary
Jana Ivanidze, MD/PhD
jai9018@med.cornell.edu
212-746-4587
Backup
Alexis Watson
alw4020@med.cornell.edu
646-962-2347
Time Frame
Start Date: 2023-12-27
Estimated Completion Date: 2026-12
Participants
Target number of participants: 20
Treatments
Experimental: ER Positive Breast Cancer Patients with Brain Metastases
A 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.
Related Therapeutic Areas
Sponsors
Collaborators: GE Healthcare
Leads: Weill Medical College of Cornell University

This content was sourced from clinicaltrials.gov