NCT06072807 Brain [18F]-FES PET/CT in Patients With Estrogen-Receptor Positive Breast Cancer
| NCT ID | NCT06072807 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Weill Medical College of Cornell University |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-12-27 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 20 participants in total. It began in 2023-12-27 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Jana Ivanidze, MD/PhD
PRINCIPAL INVESTIGATOR
Weill Medical College of Cornell University
Frequently Asked Questions
Who can join the NCT06072807 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06072807 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06072807 currently recruiting?
Yes, NCT06072807 is actively recruiting participants. Contact the research team at jai9018@med.cornell.edu for enrollment information.
Where is the NCT06072807 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06072807 clinical trial?
NCT06072807 is sponsored by Weill Medical College of Cornell University. The principal investigator is Jana Ivanidze, MD/PhD at Weill Medical College of Cornell University. The trial plans to enroll 20 participants.
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