What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography

Uterine Fibroids Clinical Trial

Official title:

What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01992718
• Other study ID #: HUM00076620
• Status: Completed
• Phase: Early Phase 1
• Start date: November 2013
• Est. completion date: March 2018

Study information

• Verified date: May 2018
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Adenomyosis
• Leiomyoma
• Uterine Bleeding
• Uterine Fibroids
• Uterine Hemorrhage

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	Association of University Radiologists, GE Radiology Research Academic Fellowship

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1-2 months per patient
Secondary	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	6 months per patient