Back to results[18F]Fluoroestradiol-PET/CT Companion Imaging Study to the FORESEE Trial
Primary Purpose
Estrogen Receptor Positive Breast Cancer
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
[18F]Fluoroestradiol (FES) PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Estrogen Receptor Positive Breast Cancer
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.
Sites / Locations
- Huntsman Cancer Institute at University of UtahRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment: all patients
Arm Description
One session of [18F]FES PET/CT Imaging
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04727632
Brief Title
[18F]Fluoroestradiol-PET/CT Companion Imaging Study to the FORESEE Trial
Official Title
[18F]Fluoroestradiol-PET/CT Companion Imaging Study to the FORESEE: Functional Precision Oncology for Metastatic Breast Cancer Feasibility Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2021 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Estrogen Receptor Positive Breast Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment: all patients
Arm Type
Experimental
Arm Description
One session of [18F]FES PET/CT Imaging
Intervention Type
Drug
Intervention Name(s)
[18F]Fluoroestradiol (FES) PET/CT
Intervention Description
[18F]Fluoroestradiol (FES) PET/CT
Primary Outcome Measure Information:
Title
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
Description
establish proof-of-concept to inform use of FES-PET/CT in future larger precision oncology trials
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Rate of concordance between FES-PET/CT imaging (positive or negative uptake) and ER status from tumor biopsy
Description
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
Time Frame
12 weeks
Title
Rate of concordance between positive FES-PET/CT scan and response to hormonal therapies from drug profiling results using patient-derived organoid models
Description
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
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paige Nielsen
Phone
801-585-5942
Email
paige.nielsen@hci.utah.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Covington, MD
Phone
801-585-5942
Email
matthew.covington@hsc.utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Covington, MD
Organizational Affiliation
Huntsman Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huntsman Cancer Institute at University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matt Covington, MD
Phone
801-585-5942
Email
matt.covington@hci.utah.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
[18F]Fluoroestradiol-PET/CT Companion Imaging Study to the FORESEE Trial
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