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OpenTrials
Completed

NCT Number: NCT01992718

What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 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).

-

Exclusion criteria

  • 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 -

Treatment and study plan

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.

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.

Primary outcomes

  1. Diagnostic accuracy of MRI and ultrasound elastography for distinguishing adenomyosis and fibroids

    Time frame: 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 outcomes

  1. Patient preference between ultrasound and MRI

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Association of University Radiologists
  • GE Radiology Research Academic Fellowship

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Nov 25, 2013
Registry last updated
May 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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