Back to resultsEvaluating Endometriosis With 16α-(18)F-fluoro-17β-estradiol ([F-18] FES) PET/MRI
Primary Purpose
Endometriosis
Status
Enrolling by invitation
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
F-18 FES
Sponsored by
About this trial
This is an interventional diagnostic trial for Endometriosis
Eligibility Criteria
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)
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
F-18 FES PET/MRI
Arm Description
16α-(18)F-fluoro-17β-estradiol ([F-18] FES)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04347135
Brief Title
Evaluating Endometriosis With 16α-(18)F-fluoro-17β-estradiol ([F-18] FES) PET/MRI
Official Title
Pilot Study Evaluating Endometriosis With 16α-(18)F-fluoro-17β-estradiol ([F-18] FES) PET/MRI
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 7, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Annie (Annie) T. Packard
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Researchers are trying to improve the detection of endometriosis using F-18 FES PET/MRI imaging.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
F-18 FES PET/MRI
Arm Type
Experimental
Arm Description
16α-(18)F-fluoro-17β-estradiol ([F-18] FES)
Intervention Type
Drug
Intervention Name(s)
F-18 FES
Intervention Description
F-18 FES PET/MRI for detection of endometriosis.
Primary Outcome Measure Information:
Title
Detection of Endometriosis
Description
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.
Time Frame
24 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Packard, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Evaluating Endometriosis With 16α-(18)F-fluoro-17β-estradiol ([F-18] FES) PET/MRI
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