ClinicalTrials.Veeva

Menu

Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone PET / MRI

University of North Carolina (UNC) logo

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

24 participants in 1 patient group

18F-fluorofuranylnorprogesterone PET / MRI
Experimental group
Description:
All enrolled subjects will receive the tracer and then have a PET/MRI scan.
Treatment:
Drug: 18F-fluorofuranylnorprogesterone PET / MRI

Trial contacts and locations

1

Loading...

Central trial contact

Hannah Mignosa-Martin; Markeela Lipscomb, CCRC

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems