What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography
Uterine Bleeding - Uterine Fibroids - Adenomyosis
Conditions: official terms
Adenomyosis - Leiomyoma - Myofibroma - Uterine Hemorrhage
Study Type
Study Phase
Phase 0
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Name: ARM 1: Evaluation of MRI, US for pelvic and uterine conditions Type: Procedure
Name: ARM 2 Patient preference between MRI and Ultrasound Type: Procedure
Overall Status
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 and we will also evaluate which exam patients prefer over another exam.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

1. 18 years of age or older

2. Scheduled for a hysterectomy for either pelvic pain and/or abnormal uterine bleeding. (this is specific for Arm. 1 of this study)

3. If you have recently had a MRI(magnetic resonance imaging)and are scheduled for, or have recently undergone a pelvic ultrasound. (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 -
University of Michigan Hospital
Ann Arbor, Michigan, United States
Status: Recruiting
Contact: Katherine Maturen, M.D. - 734-232-6004
Start Date
November 2013
Completion Date
November 2019
University of Michigan
University of Michigan
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page