Status:
COMPLETED
Evaluation of Endometriosis With 18F-fluoroestradiol PET / MRI
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
North Carolina Translational and Clinical Sciences Institute
Conditions:
Endometriosis
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 recru...
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 obj...
Eligibility Criteria
Inclusion
- 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
- Male
- Institutionalized subject (prisoner or nursing home patient)
- Known history of breast, ovarian or endometrial cancer.
- Pregnant or breast-feeding women
Key Trial Info
Start Date :
August 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04382911
Start Date
August 7 2020
End Date
July 11 2022
Last Update
May 30 2023
Active Locations (1)
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1
UNC Hospitals
Chapel Hill, North Carolina, United States, 27599