What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography

Early Phase 1CompletedNCT01992718

University of Michigan49 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Uterine Bleeding Uterine Fibroids Adenomyosis

Interventions

Evaluation of MRI, US for pelvic and uterine conditionsPROCEDURE

Pelvic ultrasound with transabdominal and transvaginal imaging. The transvaginal ultrasound will include elastography (TVUS-E). Also, a pelvic MRI will be performed if not done in the last 6 months. The MRI is performed with IV gadolinium-based contrast (MultiHance ®). A patient survey will be included.

Patient preference between MRI and UltrasoundPROCEDURE

Subjects may take part in this arm because they have recently had a MRI performed and scheduled for, or have recently undergone a pelvic ultrasound. Subjects will also be asked to complete a survey that will state their preference with regards to examination/imaging. This will be done over the phone and will take no longer than 30 minutes to complete.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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). \- 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 -

Locations (1)

University of Michigan Hospital

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Diagnostic accuracy of MRI and ultrasound elastography for distinguishing adenomyosis and fibroids

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

Time frame: 1-2 months per patient

Secondary Outcomes

Patient preference between ultrasound and MRI

Patients will take a survey to assess their experiences and preferences for pelvic imaging tests within 6 months after having those tests

Time frame: 6 months per patient

Data from ClinicalTrials.gov

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