Trials / Completed
CompletedNCT01992718
What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- University of Michigan · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2013-11-01
- Primary completion
- 2018-03-01
- Completion
- 2018-03-01
- First posted
- 2013-11-25
- Last updated
- 2018-05-31
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01992718. Inclusion in this directory is not an endorsement.