What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography

Early Phase 1

Completed

• Conditions: Uterine Bleeding; Uterine Fibroids; Adenomyosis
• Interventions: Procedure: Patient preference between MRI and Ultrasound; Procedure: Evaluation of MRI, US for pelvic and uterine conditions

• Registration Number: NCT01992718
• Lead Sponsor: University of Michigan

Brief Summary

To improve the clinical care of women with pelvic pain and abnormal uterine bleeding due to benign uterine conditions including leiomyomas (uterine fibroids) and adenomyosis by evaluating the accuracy of radiology diagnostic exams (MRI(magnetic resonance imaging), ultrasound and ultrasound with elastography).

Detailed Description

Currently benign conditions of the uterus are frequently underdiagnosed or misdiagnosed. This project will help determine which diagnostic radiology exams are most helpful to the clinician in providing accurate diagnosis. In addition, this study will evaluate which exam (MRI vs. Ultrasound) patients prefer over another exam.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-07
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-25
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-30
• Last Update Posted: 2018-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 49

Inclusion Criteria

1. 18 years of age or older

2. Pelvic pain and/or abnormal uterine bleeding. (this is specific for Arm. 1 of this study)

3. If you have had or are scheduled to have both a pelvic MRI (magnetic resonance imaging) and a pelvic ultrasound with 6 months of the time of enrollment. (this is specific to Arm 2 of this study).

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Exclusion Criteria

1. If you are post-menopausal(have not had a period in at least one year's time).
2. If you have been diagnosed with gynecological malignancy such as uterine, endometrial, cervical or ovarian cancer.
3. If you are unable or unwilling to sign the informed consents
4. If you are unable to undergo the research study exams -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient preference MRI vs. US	Patient preference between MRI and Ultrasound	We are asking subjects to evaluate patient preference between MRI (magnetic resonance imaging) and ultrasound to determine which they would rather undergo.
Evaluation of MRI, US for pelvic conditions	Evaluation of MRI, US for pelvic and uterine conditions	MRI and ultrasound imaging will be used clinically to evaluate pelvic pain and abnormal uterine bleeding. The goal is to determine which exams are most helpful to the clinician in providing an accurate diagnosis as well as evaluating patient preference.

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of MRI and ultrasound elastography for distinguishing adenomyosis and fibroids	1-2 months per patient	Arm 1 patients will undergo hysterectomy (per previously defined clinical decision unrelated to the study) 4-6 weeks after enrollment and imaging tests, allowing us to correlate imaging and pathologic findings

Secondary Outcome Measures

Name	Time	Method
Patient preference between ultrasound and MRI	6 months per patient	Patients will take a survey to assess their experiences and preferences for pelvic imaging tests within 6 months after having those tests

Trial Locations

Locations (1)

University of Michigan Hospital; 🇺🇸 Ann Arbor, Michigan, United States