An Early Phase 1 interventional study of Evaluation of MRI, US for pelvic and uterine conditions and Patient preference between MRI and Ultrasound in Uterine Bleeding, Uterine Fibroids and Adenomyosis, sponsored by University of Michigan. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-31.
Sponsored by University of Michigan · Early Phase 1, Interventional, and Diagnostic
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.
490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.
This study's enrollment of 49 is below the median of 62 across 345 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
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Exclusion Criteria:
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
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
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.
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
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
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
Plan to share: No
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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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