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NCT Number: NCT04382911

Evaluation of Endometriosis With 18F-fluoroestradiol PET / MRI

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

UNC Hospitals

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18F-Fluoroestradiol

Drug

Patients will receive the FES tracer during a PET/MRI scan

Other names: FES

Primary outcomes

  1. Sensitivity of FES PET/MRI for Evaluating Endometriosis (Percentage of Positive Scans)

    Time frame: day of scan, up to 2 hours

    The sensitivity of FES PET /MRI is defined as the ability of readers (radiologists) to detect endometriosis among those with histopathologically identified endometriosis in the entire cohort. Sensitivity is calculated by dividing the number of true cases of endometriosis by the overall number of patients with endometriosis identified using the research imaging. The sensitivity data can only be calculated upon completion of study imaging for all participants.

  2. Specificity of FES PET/MRI for Evaluating Endometriosis (Percentage of Negative Scans)

    Time frame: day of scan, up to 2 hours

    The specificity of FES PET /MRI is defined as the ability of readers (radiologists) to detect that patients do not have endometriosis divided by the number of participants without endometriosis as defined histopathologically in the entire cohort. Specificity is calculated by dividing the number of true negative cases by the overall number of patients without endometriosis identified using the research imaging. The specificity data can only be calculated upon completion of study imaging for all participants.

Secondary outcomes

  1. Correlation of the FES PET/MRI Specificity to Conventional MRI

    Time frame: day of scan, up to 2 hours

    The investigators will use McNemar's test, constructing the 2x2 table among all patients with a surgical diagnosis of negative to compare specificity for FES PET/MRI (Outcome Measure 2) versus conventional MRI. The specificity of FES PET /MRI is defined as the ability of readers (radiologists) to detect that patients do not have endometriosis divided by the number of participants without endometriosis as defined histopathologically in the entire cohort. Specificity is calculated by dividing the number of true negative cases by the overall number of patients without endometriosis identified using the research imaging. The specificity data can only be calculated upon completion of study imaging for all participants.

  2. Mean Standard Uptake Values (SUV-max) for 18F-fluoroestradiol PET / MRI

    Time frame: day of scan, up to 2 hours

    The SUV-max is the maximum standardized uptake value for FES within the tissue.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • North Carolina Translational and Clinical Sciences Institute

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 11, 2020
Registry last updated
May 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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