Status:
TERMINATED
[18F]Fluoroestradiol-PET/CT Companion Imaging Study to the FORESEE Trial
Lead Sponsor:
University of Utah
Conditions:
Estrogen Receptor Positive Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
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 deci...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2024
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04727632
Start Date
March 31 2021
End Date
July 30 2024
Last Update
October 28 2024
Active Locations (1)
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1
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112