Clinical trial · Interventional
[18F]Fluoroestradiol-PET/CT Companion Imaging Study to the FORESEE Trial
[18F]Fluoroestradiol-PET/CT Companion Imaging Study to the FORESEE: Functional Precision Oncology for Metastatic Breast Cancer Feasibility Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): It was not feasible to perform FES PET/CT
Summary
Brief summary (as posted)
This protocol is a companion imaging study that will add FES-PET/CT imaging to the FORESEE trial at HCI. This study will establish the feasibility of using FES-PET/CT imaging to guide therapeutic decision making for functional precision oncology trials. The unique ability of FES-PET/CT to show absence of functional estrogen receptors throughout the entire body may improve confidence among research oncologists that an ER+ metastatic breast cancer patient is truly refractory to hormonal therapies which is a critical determination in the study design of the FORESEE trial.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Estrogen Receptor Positive Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]Fluoroestradiol (FES) PET/CT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment: all patients
- description
- One session of \[18F\]FES PET/CT Imaging
- interventionNames
- Drug: [18F]Fluoroestradiol (FES) PET/CT
Primary outcomes (1)
- measure
- Number of patients on the FORESEE trial refractory to all combinatorial hormonal therapies that are recruited and imaged with FES-PET/CT prior to switching to non-hormonal therapeutic agents
- timeFrame
- 12 weeks
- description
- establish proof-of-concept to inform use of FES-PET/CT in future larger precision oncology trials
Secondary outcomes (2)
- measure
- Rate of concordance between FES-PET/CT imaging (positive or negative uptake) and ER status from tumor biopsy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults aged 18 years or greater. * All patients or legal guardians are willing and able to sign written informed consent and HIPAA authorization in accordance with local and institutional guidelines. * Enrolled on the FORESEE trial. * Biopsy proven estrogen receptor positive breast cancer. * Patient deemed refractory to all combinations of hormonal therapies by FORESEE trial investigators. Exclusion Criteria: * Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion. * Patients who require monitored anesthesia for PET/CT scanning. * Patients who are too claustrophobic to undergo PET/CT scanning. * Patients who are pregnant or currently breast feeding. * Any patient that is medically unstable defined as a patient requiring inpatient hospitalization or needing evaluation at an acute care or urgent care facility at the time of imaging.
References
Publications (0)
Data not yet available