Pfizer COVID-19 vaccine appointments are available to our patients. Sign up for Connect today to schedule your vaccination.

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

Clinical Trial Details

This study is evaluating whether position emission tomography (PET) imaging of the brain using 18F-FES can better detect and better provide targeted treatment of brain metastases in patients with endocrin resistant (ER)-positive breast cancer.  

Although PET imaging using 18F-FES is approved by the U.S. Food and Drug Administration (FDA) for the detection of ER-positive lesions in patients with recurrent or metastatic breast cancer, there is limited information about whether dedicated brain PET/CT imaging with this radiotracer can detect and help guide treatment of brain metastases. 

Participants will be asked to undergo a PET/CT scan of their head using 18F- FES for research purposes. This scan will be completed prior to the planned standard of care radiation therapy. 

Participants will be followed for a period of up to 12 months with routine standard-of-care clinical follow-up with their clinical care team. Information from medical records relating to radiation treatment, and follow-up clinical and magnetic resonance imaging (MRI) assessments will be extracted from participants' medical records from their standard of care visits and will be used for research purposes. 

Key Eligibility: 

INCLUSION CRITERIA

  1. Open to women 18 years of age or older, who have an active diagnosis of estrogen receptor-positive (ER+) breast cancer and new or recurrent brain metastases (biopsy proven or suspected based on MRI appearance)
  2. Discontinuation of estrogen receptor (ER) modulators for at least 8 weeks, and discontinuation of ER down regulators for at least 28 weeks 
  3. Life expectancy of greater than 6 months
  4. Planned for radiation treatment for brain metastases

EXCLUSION CRITERIA

  1. Pregnancy
  2. Unable to undergo Standard of Care
  3. Allergy to FES.

 Detailed eligibility will be discussed when contacting the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

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

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2302025733

ClinicalTrials.gov:

NCT06072807

Status

Not Yet Recruiting

Age Group

Adult

Sponsor