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NCT04347135 Clinical Trial

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

Endometriosis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04347135
Other study ID # 19-004345
Secondary ID
Status Withdrawn
Phase Phase 1/Phase 2
First received
Last updated
Start date October 7, 2022
Est. completion date April 30, 2024

Study information
Verified date April 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date April 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• F-18 FES
F-18 FES PET/MRI for detection of endometriosis.

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Annie (Annie) T. Packard

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Detection of Endometriosis 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. 24 months
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