Adenomyosis, Uterine Bleeding, Uterine Fibroids
Conditions
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.
Interventions
PROCEDUREEvaluation 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.
PROCEDUREPatient 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.
Sponsors
Association of University Radiologists
GE Radiology Research Academic Fellowship
University of Michigan
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of MRI and ultrasound elastography for distinguishing adenomyosis and fibroids | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient preference between ultrasound and MRI | 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 |
Countries
United States
Outcome results
None listed