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

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ClinicalTrials.gov Identifier: NCT04727632
Recruitment Status : Recruiting
First Posted : January 27, 2021
Last Update Posted : April 22, 2022
Sponsor:
Information provided by (Responsible Party):
University of Utah

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.

Condition or disease Intervention/treatment Phase
Estrogen Receptor Positive Breast Cancer Drug: [18F]Fluoroestradiol (FES) PET/CT Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: [18F]Fluoroestradiol-PET/CT Companion Imaging Study to the FORESEE: Functional Precision Oncology for Metastatic Breast Cancer Feasibility Trial
Actual Study Start Date : March 31, 2021
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : April 30, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment: all patients
One session of [18F]FES PET/CT Imaging
Drug: [18F]Fluoroestradiol (FES) PET/CT
[18F]Fluoroestradiol (FES) PET/CT




Primary Outcome Measures :
  1. 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 [ Time Frame: 12 weeks ]
    establish proof-of-concept to inform use of FES-PET/CT in future larger precision oncology trials


Secondary Outcome Measures :
  1. Rate of concordance between FES-PET/CT imaging (positive or negative uptake) and ER status from tumor biopsy [ Time Frame: 12 weeks ]
    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

  2. Rate of concordance between positive FES-PET/CT scan and response to hormonal therapies from drug profiling results using patient-derived organoid models [ Time Frame: 12 weeks ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04727632


Contacts
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Contact: Paige Nielsen 801-585-5942 paige.nielsen@hci.utah.edu
Contact: Matthew Covington, MD 801-585-5942 matthew.covington@hsc.utah.edu

Locations
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United States, Utah
Huntsman Cancer Institute at University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Matt Covington, MD    801-585-5942    matt.covington@hci.utah.edu   
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Matthew Covington, MD Huntsman Cancer Institute
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Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT04727632    
Other Study ID Numbers: HCI140278
First Posted: January 27, 2021    Key Record Dates
Last Update Posted: April 22, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases