What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography

NCT01992718 | Completed Early Phase 1 DMC

• 1 other identifier: HUM00076620
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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).

Conditions

Uterine Bleeding; Uterine Fibroids; Adenomyosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient preference between ultrasound and MRI

  6 months per patient

Study Arms (2)

Evaluation of MRI, US for pelvic conditions

ACTIVE COMPARATOR

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

Patient preference MRI vs. US

ACTIVE COMPARATOR

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

Interventions

Evaluation of MRI, US for pelvic and uterine conditions PROCEDURE

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.

Evaluation of MRI, US for pelvic conditions

Patient preference between MRI and Ultrasound PROCEDURE

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.

Patient preference MRI vs. US

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Pelvic pain and/or abnormal uterine bleeding. (this is specific for Arm. 1 of this study)
• 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).

You may not qualify if:

• If you are post-menopausal(have not had a period in at least one year's time).
• If you have been diagnosed with gynecological malignancy such as uterine, endometrial, cervical or ovarian cancer.
• If you are unable or unwilling to sign the informed consents
• If you are unable to undergo the research study exams -

Sponsors & Collaborators

• University of Michigan: lead
• Association of University Radiologists: collaborator
• GE Radiology Research Academic Fellowship: collaborator

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Uterine Hemorrhage; Leiomyoma; Adenomyosis

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Katherine Maturen, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: November 25, 2013
• Study Start: November 1, 2013
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: May 31, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)