[18F]Fluoroestradiol-PET/CT Companion Imaging Study to the FORESEE Trial
Purpose
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.
Condition
- Estrogen Receptor Positive Breast Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- This is a companion imaging study to IRB # 131027 FORESEE: Functional precision oncology for metastatic breast cancer: a feasibility trial. This companion imaging study will obtain [18F]Fluoroestradiol (FES)-PET/CT imaging of breast cancer patients refractory to all combinatorial hormonal therapies enrolled in the FORESEE trial and correlate the FES-PET/CT results with data from FORESEE including estrogen receptor (ER) status and drug profiling results from patient-derived organoid models.
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment: all patients |
One session of [18F]FES PET/CT Imaging |
|
Recruiting Locations
More Details
- NCT ID
- NCT04727632
- Status
- Terminated
- Sponsor
- University of Utah