What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by University of Michigan
Sponsor:
Collaborators:
Association of University Radiologists
GE Radiology Research Academic Fellowship
Information provided by (Responsible Party):
Katherine Maturen, M.D., University of Michigan
ClinicalTrials.gov Identifier:
NCT01992718
First received: November 7, 2013
Last updated: May 22, 2015
Last verified: May 2015
  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: ARM 1: Evaluation of MRI, US for pelvic and uterine conditions
Procedure: ARM 2 Patient preference between MRI and Ultrasound
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Patients will take a survey to assess their experiences and preferences for pelvic imaging tests within 6 months after having those tests


Estimated Enrollment: 150
Study Start Date: November 2013
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ARM 1 Evaluation MRI, US for pelvic conditions
MRI and ultrasound imaging used clinically to evaluate pelvic pain and abnormal uterine bleeding and determine which exams are most helpful to the clinician in providing an accurate diagnosis as well as evaluation patient preference.
Procedure: ARM 1: 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: ARM 2 Patient preference MRI vs. US
We are asking subjects to evaluate patient preference between MRI (magnetic resonance imaging) and ultrasound
Procedure: ARM 2 Patient preference between MRI and Ultrasound

Subjects may take part in ARM 2 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 and we will also evaluate which exam patients prefer over another exam.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age or older
  2. Scheduled for a hysterectomy for either pelvic pain and/or abnormal uterine bleeding. (this is specific for Arm. 1 of this study)
  3. If you have recently had a MRI(magnetic resonance imaging)and are scheduled for, or have recently undergone a pelvic ultrasound. (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01992718

Contacts
Contact: Katherine Maturen, M.D. 734-232-6004 kmaturen@med.umich.edu
Contact: Ladonna Austin, CCRC 734-936-8275 ladonna@med.umich.edu

Locations
United States, Michigan
University of Michigan Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Katherine Maturen, M.D.    734-232-6004      
Contact: Ladonna Austin, M.D.    734-936-8275    ladonna@med.umich.edu   
Principal Investigator: Katherine Maturen, M.D.         
Sponsors and Collaborators
University of Michigan
Association of University Radiologists
GE Radiology Research Academic Fellowship
Investigators
Principal Investigator: Katherine Maturen, M.D. University of Michigan
  More Information

No publications provided

Responsible Party: Katherine Maturen, M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01992718     History of Changes
Other Study ID Numbers: HUM00076620
Study First Received: November 7, 2013
Last Updated: May 22, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 28, 2015