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What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01992718
First Posted: November 25, 2013
Last Update Posted: October 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Association of University Radiologists
GE Radiology Research Academic Fellowship
Information provided by (Responsible Party):
Katherine Maturen, M.D., University of Michigan
  Purpose
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 Intervention 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Katherine Maturen, M.D., University of Michigan:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


Enrollment: 49
Actual Study Start Date: November 2013
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 -
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992718


Locations
United States, Michigan
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
  More Information

Responsible Party: Katherine Maturen, M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01992718     History of Changes
Other Study ID Numbers: HUM00076620
First Submitted: November 7, 2013
First Posted: November 25, 2013
Last Update Posted: October 25, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Uterine Hemorrhage
Adenomyosis
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Uterine Diseases
Genital Diseases, Female
Hemorrhage
Pathologic Processes