Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 and up Women only

Using 18F-FES PET/CT imaging for breast cancer patients with brain metastases

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

Run by Weill Medical College of Cornell University · NCT06072807 · Data updated 2026-11-12

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.

More Breast Cancer trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment20 (estimated)
SponsorWeill Medical College of Cornell University
Academic / other
Drugs / interventionsradiation
Locations1 site (New York, New York)
StatusRecruiting
StartedDecember 27, 2023
Main results expectedDecember 2027
Study endsDecember 2027
Registry record updatedOctober 29, 2026
Trial IDNCT06072807 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients who are pregnant, unable to undergo standard care, or have allergies to FES may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.