[18F]Fluoroestradiol-PET/CT Companion Imaging Study to the FORESEE Trial

Utah System of Higher Education (USHE)

Status and phase: Terminated; Early Phase 1

Conditions: Estrogen Receptor Positive Breast Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04727632

HCI140278

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Treatment: all patients

Experimental group

Description:

One session of \[18F\]FES PET/CT Imaging

Treatment:

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