NCT06072807

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4 breast-cancer

Timeline
19mo left

Started Dec 2023

Typical duration for phase_4 breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Dec 2023Dec 2027

First Submitted

Initial submission to the registry

October 2, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

December 27, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

3.9 years

First QC Date

October 2, 2023

Last Update Submit

November 18, 2025

Conditions

Breast CancerBrain Metastases

Outcome Measures

Primary Outcomes (6)

  • Mean SUV

    Mean standardized uptake value within a region of interest placed based on MRI findings of suspicious brain lesion.

    3 years

  • Maximum SUV

    Maximum standardized uptake value within a region of interest placed based on MRI findings of suspicious brain lesion.

    3 years

  • SUV Ratio

    Standardized uptake value ratio of target lesion over reference region.

    3 years

  • Target-to-Background Ratio

    Qualitative appearance of lesion delineation on PET.

    3 years

  • Influx (Ki)

    Parametric PET analysis results within the same region of interest as that for Maximum SUV.

    3 years

  • Distribution volume (Vt) for scan times

    Distribution volume (Vt), measured within the same region of interest as that for Maximum SUV, for scan times ranging between 45 min and 85 min with 5min intervals and corresponding results will be compared to those measured with the full dataset at 90mm.

    3 years

Secondary Outcomes (1)

  • Proportion of cases in which there was a change in management based on FES PET/CT

    3 years

Study Arms (1)

ER Positive Breast Cancer Patients with Brain Metastases

EXPERIMENTAL

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.

Diagnostic Test: Brain Imaging with 18F-FES

Interventions

Brain Imaging with 18F-FESDIAGNOSTIC_TEST

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

ER Positive Breast Cancer Patients with Brain Metastases

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Unable to undergo Standard of Care
  • Allergy to FES.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York-Presbyterian/Weill Cornell Medical Center

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsBrain Neoplasms

Interventions

Neuroimaging

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Officials

  • Jana Ivanidze, MD/PhD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jana Ivanidze, MD/PhD

CONTACT

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

Alexis Watson

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2023

First Posted

October 10, 2023

Study Start

December 27, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)