Evaluating Endometriosis With 16α-(18)F-fluoro-17β-estradiol ([F-18] FES) PET/MRI

Phase 1

Withdrawn

• Conditions: Endometriosis
• Interventions: Drug: F-18 FES

• Registration Number: NCT04347135
• Lead Sponsor: Annie (Annie) T. Packard

Brief Summary

Researchers are trying to improve the detection of endometriosis using F-18 FES PET/MRI imaging.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-13
• Study First Submitted QC: 2020-04-13
• Study First Posted: 2020-04-15
• Study Start: 2022-10-07
• Status Verified: 2024-04
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Premenopausal women (18-50) with endometriosis

Exclusion Criteria

• Postmenopausal women
• AP diameter when lying supine greater than 32 cm (too large for PET/MRI)
• Unable to undergo PET/MRI for any reason (metal implants, severe claustrophobia)
• Unable to receive IV Gadolinium contrast for any reason (renal failure eGFR < 60, contrast allergy)
• Pregnant (Urine test will be provided for all patients)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
F-18 FES PET/MRI	F-18 FES	16α-(18)F-fluoro-17β-estradiol (\[F-18\] FES)

Primary Outcome Measures

Name	Time	Method
Detection of Endometriosis	24 months	Comparisons will be made descriptively between conventional MRI imaging, FES PET/MRI imaging and surgical/pathologic findings. Outcome data include number of detected lesions, differences in the accuracy for detection of active disease versus inactive fibrosis, and confidence score.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States