Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone PET / MRI

University of North Carolina (UNC)

Status and phase

Enrolling

Phase 2

Conditions

Endometriosis

Treatments

Drug: 18F-fluorofuranylnorprogesterone PET / MRI

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05480995

1P01HD106485-01 (U.S. NIH Grant/Contract)

22-1175

Details and patient eligibility

About

Purpose: The aim of this study is to assess the sensitivity and specificity of FFNP PET/MRI for diagnosis of endometriosis.

Participants: A total of 24 participants will be recruited from individuals with clinically suspected endometriosis.

Procedures (methods): This is a prospective, one arm, single center study of 24 subjects with clinically suspected endometriosis to demonstrate FFNP PET-MRI's clinical utility for diagnosis of endometriosis.

Enrollment

24 estimated patients

Sex

Female

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Age 18 or older
Female of childbearing age (18-55 years)
Clinically suspected (symptomatic) endometriosis as defined by referring physician (this would also include endometriomas as other disease may be present).
Scheduled for planned operative laparoscopy with no hormone treatment for at least two cycles
Able to provide informed consent

Exclusion Criteria

Male
Institutionalized subject (prisoner or nursing home patient)
Known history of breast, ovarian or endometrial cancer.
Pregnant or breast-feeding women
Chronic progestin-containing medications or Gonadotropin-releasing hormone (GnRH) analogues in the last 10-16 days (or 2 cycles in the case of GnRH analogues as these are dosed monthly) or inability to discontinue these medications
Allergy to gadolinium contrast or Glomerular Filtration Rate (GFR) below 30 ml/min.