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

NCT ID: NCT04347135

Last Updated: 2024-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-07

Study Completion Date

2024-04-30

Brief Summary

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

Detailed Description

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Conditions

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Endometriosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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F-18 FES PET/MRI

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

Group Type EXPERIMENTAL

F-18 FES

Intervention Type DRUG

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

Interventions

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F-18 FES

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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Annie (Annie) T. Packard

OTHER

Sponsor Role lead

Responsible Party

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Annie (Annie) T. Packard

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ann Packard, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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19-004345

Identifier Type: -

Identifier Source: org_study_id

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