What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography
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|ClinicalTrials.gov Identifier: NCT01992718|
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : May 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Uterine Bleeding Uterine Fibroids Adenomyosis||Procedure: Evaluation of MRI, US for pelvic and uterine conditions Procedure: Patient preference between MRI and Ultrasound||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography|
|Actual Study Start Date :||November 2013|
|Actual Primary Completion Date :||March 2018|
|Actual Study Completion Date :||March 2018|
Active Comparator: Evaluation of MRI, US for pelvic 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.
Procedure: Evaluation of MRI, US for pelvic and uterine conditions
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.
Active Comparator: Patient preference MRI vs. US
We are asking subjects to evaluate patient preference between MRI (magnetic resonance imaging) and ultrasound to determine which they would rather undergo.
Procedure: Patient preference between MRI and Ultrasound
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.
- Diagnostic accuracy of MRI and ultrasound elastography for distinguishing adenomyosis and fibroids [ Time Frame: 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
- Patient preference between ultrasound and MRI [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992718
|United States, Michigan|
|University of Michigan Hospital|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Katherine Maturen, MD, MS||University of Michigan|