Clinical trial NCT04727632: [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
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Estrogen Receptor Positive Breast Cancer
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: 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
timeFrame: 12 weeks
Secondary outcomes:
measure: Rate of concordance between FES-PET/CT imaging (positive or negative uptake) and ER status from tumor biopsy
timeFrame: 12 weeks
measure: Rate of concordance between positive FES-PET/CT scan and response to hormonal therapies from drug profiling results using patient-derived organoid models
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute at University of Utah
state: Utah
Study officials:
affiliation: Huntsman Cancer Institute
name: Matthew Covington, MD
role: PRINCIPAL_INVESTIGATOR
References: