What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography

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Brief Title

What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography

Official Title

What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography

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.

Study Phase

Early Phase 1

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

 Patient preference between ultrasound and MRI

Condition

Uterine Bleeding

Intervention

Evaluation of MRI, US for pelvic and uterine conditions

Study Arms / Comparison Groups

 Evaluation of MRI, US for pelvic conditions
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

49

Start Date

November 2013

Completion Date

March 2018

Primary Completion Date

March 2018

Eligibility Criteria

        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 -

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Katherine Maturen, MD, MS, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT01992718

Organization ID

HUM00076620

Responsible Party

Principal Investigator

Study Sponsor

University of Michigan

Collaborators

 Association of University Radiologists

Study Sponsor

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

Verification Date

May 2018