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

Sponsor

Annie (Annie) T. Packard (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04347135

Collaborator

(none)

Enrollment

Location

Arm

5.9

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Drug: F-18 FES	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: F-18 FES PET/MRI 16α-(18)F-fluoro-17β-estradiol ([F-18] FES)	Drug: F-18 FES F-18 FES PET/MRI for detection of endometriosis.

Arm

Intervention/Treatment

Experimental: F-18 FES PET/MRI

16α-(18)F-fluoro-17β-estradiol ([F-18] FES)

Drug: F-18 FES

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Annie (Annie) T. Packard

Investigators

Principal Investigator: Ann Packard, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Annie (Annie) T. Packard, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT04347135

Other Study ID Numbers:

19-004345

First Posted:

Apr 15, 2020

Last Update Posted:

Jul 28, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Endometriosis

Study Results

No Results Posted as of Jul 28, 2022