Recruiting • Phase NA • Stage IV • ER positive • Post-Menopausal • Interventional

The following is imported from ClinicalTrials.gov:

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

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 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.

Description

Study Design

Eligibility Criteria

Arms and Intervention

• [18F]Fluoroestradiol (FES) PET/CT

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.