Recruiting

[18F]-FES PET/CT

Sponsor:

Weill Medical College of Cornell University

Code:

NCT06072807

Conditions

Breast Cancer

Brain Metastases

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Brain Imaging with 18F-FES

Study Details

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.

Conditions

Breast Cancer

Brain Metastases

Study ID

NCT06072807

Start date

Dec 27, 2023

Status verified date

Nov, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Brain Imaging with 18F-FES

Using 18F-FES radiotracer in PET/CT scan to evaluate brain metastases in ER positive breast cancer patients.

Primary outcome measure

  • Mean SUV [ Time Frame: 3 years ]
  • Maximum SUV [ Time Frame: 3 years ]
  • SUV Ratio [ Time Frame: 3 years ]
  • Target-to-Background Ratio [ Time Frame: 3 years ]
  • Influx (Ki) [ Time Frame: 3 years ]
  • Distribution volume (Vt) for scan times [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Jana Ivanidze, MD/PhD

212-746-4587jai9018@med.cornell.edu

Alexis Watson

646-962-2347alw4020@med.cornell.edu

Locations

New York-Presbyterian/Weill Cornell Medical Center

Recruiting

New York, New York, United States, 10021

Contacts

Jana Ivanidze, MD/PhD

212-746-4587jai9018@med.cornell.edu

Principal Investigator:

Jana Ivanidze, MD/PhD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Nov 24, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2025-11-24.