Brief Title
What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography
Official Title
What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography
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 Phase
Early Phase 1
Study Type
Interventional
Primary Outcome
Diagnostic accuracy of MRI and ultrasound elastography for distinguishing adenomyosis and fibroids
Secondary Outcome
Patient preference between ultrasound and MRI
Condition
Uterine Bleeding
Intervention
Evaluation of MRI, US for pelvic and uterine conditions
Study Arms / Comparison Groups
Evaluation of MRI, US for pelvic conditions
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
49
Start Date
November 2013
Completion Date
March 2018
Primary Completion Date
March 2018
Eligibility Criteria
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 -
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Katherine Maturen, MD, MS, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01992718
Organization ID
HUM00076620
Responsible Party
Principal Investigator
Study Sponsor
University of Michigan
Collaborators
Association of University Radiologists
Study Sponsor
Katherine Maturen, MD, MS, Principal Investigator, University of Michigan
Verification Date
May 2018