Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Breast Cancer

Phase:

Early Phase 1

Estimated Enrollment:

6

Study ID:

NCT04727632

Recruitment Status:

Recruiting

Sponsor:

University of Utah

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There is 1 Location for this study

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Huntsman Cancer Institute at University of Utah
Salt Lake City Utah, 84112, United States More Info
Matt Covington, MD
Contact
801-585-5942
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Early Phase 1

Estimated Enrollment:

6

Study ID:

NCT04727632

Recruitment Status:

Recruiting

Sponsor:


University of Utah

How clear is this clinincal trial information?

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