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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04347135
Recruitment Status : Enrolling by invitation
First Posted : April 15, 2020
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Annie (Annie) T. Packard, Mayo Clinic

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
Drug Information available for: Estradiol

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.




Primary Outcome Measures :
  1. Detection of Endometriosis [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04347135


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Annie (Annie) T. Packard
Investigators
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Principal Investigator: Ann Packard, MD Mayo Clinic
Additional Information:
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Responsible Party: Annie (Annie) T. Packard, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04347135    
Other Study ID Numbers: 19-004345
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female