Using 18F-FES PET/CT imaging for breast cancer patients with brain metastases
Brain [18F]-FES PET/CT in the Diagnosis, Treatment Planning and Response Assessment of Brain Metastases in Patients With Estrogen-Receptor Positive Breast Cancer
This study is testing a special type of imaging to see if it can help doctors better understand brain tumors in breast cancer patients and improve their treatment plans.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06072807 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to optimize the use of 18F-FES PET/CT imaging in patients with estrogen receptor-positive breast cancer who have brain metastases. Participants will undergo standard MRI and FDG PET/CT scans for radiation treatment planning, along with an additional 18F-FES PET/CT scan to evaluate its effectiveness in differentiating brain metastases from radiation effects. The study will follow patients for 12 months, assessing clinical outcomes and survival metrics in relation to the imaging results.
Who should consider this trial
Good fit: Ideal candidates include adults with biopsy-proven estrogen receptor-positive breast cancer and new or recurrent brain metastases who are scheduled for radiation therapy.
Not a fit: Patients who are pregnant, unable to undergo standard care, or have allergies to FES may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of radiation treatment planning for breast cancer patients with brain metastases.
How similar studies have performed: While the use of 18F-FES PET/CT is clinically approved, its application in this specific context is novel and has not been widely tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
New York, New York
- New York-Presbyterian/Weill Cornell Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jana Ivanidze, MD/PhD — Weill Medical College of Cornell University
- Study coordinator: Jana Ivanidze, MD/PhD
- Email: jai9018@med.cornell.edu
- Phone: 212-746-4587
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.