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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-31

Study Completion Date

2024-07-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Estrogen Receptor Positive Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Treatment: all patients

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

Group Type EXPERIMENTAL

[18F]Fluoroestradiol (FES) PET/CT

Intervention Type DRUG

\[18F\]Fluoroestradiol (FES) PET/CT

Interventions

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[18F]Fluoroestradiol (FES) PET/CT

\[18F\]Fluoroestradiol (FES) PET/CT

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No