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[18F]Fluoroestradiol-PET/CT Companion Imaging Study to the FORESEE Trial | Clinical Trials | Clareo Health

TERMINATEDEARLY_PHASE1

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

[18F]Fluoroestradiol-PET/CT Companion Imaging Study to the FORESEE: Functional Precision Oncology for Metastatic Breast Cancer Feasibility Trial

NCT04727632•University of Utah

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.

Locations (1)

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, United States

Key Dates

Start Date

March 31, 2021

Primary Completion Date

September 14, 2023

Completion Date

July 30, 2024

Last Updated

October 28, 2024

Enrollment

ACTUAL participants

Conditions

Estrogen Receptor Positive Breast Cancer

Interventions

[18F]Fluoroestradiol (FES) PET/CT

DRUG

FDG PET/CT in Breast Cancer Bone Mets

NCT01996046

Estrogen Receptor Positive Breast CancerBone Metastases

View study

COMPLETEDPHASE3

Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

NCT00066690

Estrogen Receptor Positive Breast CancerProgesterone Receptor Positive Tumor+6 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 28, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

FDG PET/CT in Breast Cancer Bone Mets

Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

[18F]FES PET/CT in Endocrine Refractory Breast Cancer

A Breast Cancer Treatment Decision Aid for Women Aged 70 and Older

Hydroxychloroquine in Metastatic Estrogen Receptor-Positive Breast Cancer Progressing on Hormonal Therapy