Clinical trial NCT04382911: Evaluation of Endometriosis With 18F-fluoroestradiol PET / MRI
Official title: Evaluation of Endometriosis With 18F-fluoroestradiol PET / MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: North Carolina Translational and Clinical Sciences Institute
First posted: 2020-05-11
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Purpose: The primary objective is to evaluate the sensitivity and specificity of 18F-fluoroestradiol (FES) PET/MRI for evaluating endometriosis.

Participants: A total of 12 participants will be recruited from individuals with clinically suspected endometriosis who are scheduled for planned operative laparoscopy at the University of North Carolina at Chapel Hill (UNC).

Procedures (methods): This is a prospective, one arm, single center study of 12 subjects with clinically suspected endometriosis to demonstrate FES PET/MR's clinical utility for diagnosis of endometriosis. This study will be an evaluation of the radiotracer, FES, which binds to estrogen receptors and has previously been used to study estrogen receptor expression in tumors, to detect endometriosis. Participants will undergo one FES PET/MR scan within 4 weeks prior to their scheduled surgery. Participants will also complete questionnaires regarding their condition, pain, and quality of life.

Detailed description: This is a prospective, one arm, single center study of 12 subjects with clinically suspected endometriosis to demonstrate FES PET-MRI's clinical utility for diagnosis of endometriosis. The primary objective is to evaluate the sensitivity and specificity of 18F-fluoroestradiol (FES) PET/MRI for evaluating endometriosis. Secondary objectives include comparing PET to conventional MRI, using histopathology from laparotomy as the gold standard and evaluating association of uptake values (SUV-max) with Endometriosis Health profile -30 (EHP-30) and pain rating scales, controlling for covariates.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Female of childbearing age
* Clinically suspected (symptomatic) endometriosis.
* Scheduled for planned operative laparoscopy with no hormone treatment for at least two cycles
* Able to provide informed consent or assent

Exclusion Criteria:

* Male
* Institutionalized subject (prisoner or nursing home patient)
* Known history of breast, ovarian or endometrial cancer.
* Pregnant or breast-feeding women

Primary outcomes:
measure: Sensitivity of FES PET/MRI for Evaluating Endometriosis (Percentage of Positive Scans)
timeFrame: day of scan, up to 2 hours
measure: Specificity of FES PET/MRI for Evaluating Endometriosis (Percentage of Negative Scans)
timeFrame: day of scan, up to 2 hours
Secondary outcomes:
measure: Correlation of the FES PET/MRI Specificity to Conventional MRI
timeFrame: day of scan, up to 2 hours
measure: Mean Standard Uptake Values (SUV-max) for 18F-fluoroestradiol PET / MRI
timeFrame: day of scan, up to 2 hours
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Hospitals
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Jorge Oldan, MD
role: PRINCIPAL_INVESTIGATOR
References: