Brain [18F]-FES PET/CT in Patients With Estrogen-Receptor Positive Breast Cancer
Recruiting · NCT06072807 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- Pregnancy
- Unable to undergo Standard of Care
- Allergy to FES.
Where it is running
1 location listed across 1 US state.
- New York-Presbyterian/Weill Cornell Medical Center - New York, New York, United States