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[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	Drug: [18F]Fluoroestradiol (FES) PET/CT [18F]Fluoroestradiol (FES) PET/CT

Recruiting Locations

More Details

NCT ID: NCT04727632
Status: Terminated
Sponsor: University of Utah

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.