NCT04347135

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
2.5 years until next milestone

Study Start

First participant enrolled

October 7, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

May 10, 2024

Status Verified

April 1, 2024

Enrollment Period

1.6 years

First QC Date

April 13, 2020

Last Update Submit

May 8, 2024

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

F-18 FES PET/MRI

EXPERIMENTAL

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

Drug: F-18 FES

Interventions

F-18 FESDRUG

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

F-18 FES PET/MRI

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- Premenopausal women (18-50) with endometriosis

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Ann Packard, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 13, 2020

First Posted

April 15, 2020

Study Start

October 7, 2022

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

May 10, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)