What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT01992718
• Collaborator: Association of University Radiologists (Other), GE Radiology Research Academic Fellowship (Other)
• Enrollment: 49
• Location: 1
• Arms: 2
• Actual Duration (Months): 51.9
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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).

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

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography
• Actual Study Start Date: Nov 1, 2013
• Actual Primary Completion Date: Mar 1, 2018
• Actual Study Completion Date: Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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 -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan Hospital	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan
• Association of University Radiologists
• GE Radiology Research Academic Fellowship

Investigators

• Principal Investigator: Katherine Maturen, MD, MS, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Katherine Maturen, M.D., Principal Investigator, University of Michigan
• ClinicalTrials.gov Identifier: NCT01992718
• Other Study ID Numbers: HUM00076620
• First Posted: Nov 25, 2013
• Last Update Posted: May 31, 2018
• Last Verified: May 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Leiomyoma; Uterine Hemorrhage; Adenomyosis

Study Results

No Results Posted as of May 31, 2018