NCT06072807 · Weill Medical College of Cornell University
Brain [18F]-FES PET/CT in Patients With Estrogen-Receptor Positive Breast Cancer
What this study is about
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 the usual treatment for radiation treatment planning. An additional 18F-FES PET/CT brain scan will be completed before this the usual treatment radiation treatment.
View original scientific 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.
Interventions
DIAGNOSTIC_TEST
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 measures
Mean SUV
Time frame: 3 years
Mean standardized uptake value within a region of interest placed based on MRI findings of suspicious brain lesion.
Maximum SUV
Time frame: 3 years
Maximum standardized uptake value within a region of interest placed based on MRI findings of suspicious brain lesion.
SUV Ratio
Time frame: 3 years
Standardized uptake value ratio of target lesion over reference region.
Target-to-Background Ratio
Time frame: 3 years
Qualitative appearance of lesion delineation on PET.
Influx (Ki)
Time frame: 3 years
Parametric PET analysis results within the same region of interest as that for Maximum SUV.
Distribution volume (Vt) for scan times
Time frame: 3 years
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- Unable to undergo Standard of Care
- Allergy to FES.
Where
- New York, New York
Collaborators
GE Healthcare
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 24, 2025 · Source of record for eligibility and locations