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

Study Overview
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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.

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

Conditions
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Estrogen Receptor Positive Breast Cancer

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


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment: all patients<br>One session of [18F]FES PET/CT Imaging | Drug: [18F]Fluoroestradiol (FES) PET/CT<br>* [18F]Fluoroestradiol (FES) PET/CT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients on the FORESEE trial refractory to all combinatorial hormonal therapies that are recruited and imaged with FES-PET/CT prior to switching to non-hormonal therapeutic agents | establish proof-of-concept to inform use of FES-PET/CT in future larger precision oncology trials | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of concordance between FES-PET/CT imaging (positive or negative uptake) and ER status from tumor biopsy | assess FES-PET/CT concordance with ER status from patient-derived organoid models and concordance between FES-PET/CT imaging and patient-derived organoid drug profiling results for predicting response to hormonal therapies | 12 weeks | 
| Rate of concordance between positive FES-PET/CT scan and response to hormonal therapies from drug profiling results using patient-derived organoid models | assess FES-PET/CT concordance with ER status from patient-derived organoid models and concordance between FES-PET/CT imaging and patient-derived organoid drug profiling results for predicting response to hormonal therapies | 12 weeks |