Clinical trial · Interventional
Brain [18F]-FES PET/CT in Patients With Estrogen-Receptor Positive Breast Cancer
Brain [18F]-FES PET/CT in the Diagnosis, Treatment Planning and Response Assessment of Brain Metastases in Patients With Estrogen-Receptor Positive Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brain Imaging with 18F-FES | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ER Positive Breast Cancer Patients with Brain Metastases
- description
- 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.
- interventionNames
- Diagnostic Test: Brain Imaging with 18F-FES
Primary outcomes (6)
- measure
- Mean SUV
- timeFrame
- 3 years
- description
- Mean standardized uptake value within a region of interest placed based on MRI findings of suspicious brain lesion.
- measure
- Maximum SUV
- timeFrame
- 3 years
- description
- Maximum standardized uptake value within a region of interest placed based on MRI findings of suspicious brain lesion.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available