RECRUITING

Brain [18F]-FES PET/CT in Patients With Estrogen-Receptor Positive Breast Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-12-27
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06072807

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Active diagnosis of ER+ breast cancer (biopsy proven) and new or recurrent brain metastases (biopsy proven or suspected based on MRI appearance)
  2. 2. Ability to provide informed consent
  3. 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. 4. Age \>=18 years
  5. 5. Eastern Cooperative Oncology Group performance score 0-1
  6. 6. Life expectancy \>=6 months
  7. 7. Planned for radiation treatment for brain metastases
  1. 1. Pregnancy
  2. 2. Unable to undergo Standard of Care
  3. 3. Allergy to FES.

Contacts and Locations

Study Contact

Jana Ivanidze, MD/PhD
CONTACT
212-746-4587
jai9018@med.cornell.edu
Alexis Watson
CONTACT
646-962-2347
alw4020@med.cornell.edu

Principal Investigator

Jana Ivanidze, MD/PhD
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University

Study Locations (Sites)

New York-Presbyterian/Weill Cornell Medical Center
New York, New York, 10021
United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

  • Jana Ivanidze, MD/PhD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-27
Study Completion Date2026-12

Study Record Updates

Study Start Date2023-12-27
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Cancer
  • Brain Metastases