What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Michigan
Sponsor:
Collaborators:
Asssociation 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: June 5, 2014
Last verified: June 2014
  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 of MRI, US for pelvic and uterine conditions
MRI)magnetic resonance imaging)and ultrasound imaging are used clinically to evaluate pelvic pain and abnormal uterine bleeding. Our wish is to determine which exams are most helpful to the clinician in providing an accurate diagnosis. We will also evaluate which exam patients prefer.
Procedure: ARM 1: Evaluation of MRI, US for pelvic and uterine conditions

You will undergo a pelvic ultrasound with transabdominal and transvaginal imaging, performed by a female technologist. The transvaginal ultrasound will include elastography (TVUS-E). An ultrasound probe will be inserted into your vagina and gently placed up against your cervix. Sound waves will be emitted from the probe that will bounce off various structures in your body and bounce back to the ultrasound machine to create the ultrasound images.

You will have a pelvic MRI performed if you have not had one within the last 6 months. The MRI is performed with IV gadolinium-based contrast (MultiHance ®).

The MRI scan will take approximately 60 to 90 minutes to complete. We will also ask you to participate in a survey that includes questions about your pelvic symptoms and the imaging tests you just had done.

Active Comparator: ARM 2 Patient preference between MRI and Ultrasound

We are trying to improve the clinical care of women who have pelvic pain and abnormal uterine bleeding due to certain uterine conditions including uterine fibroids (leiomyomas) and adenomyosis.

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.

The pelvic ultrasound will take approximately 30 minutes to complete.

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
Asssociation 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: June 5, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Adenomyosis
Leiomyoma
Myofibroma
Uterine Hemorrhage
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

ClinicalTrials.gov processed this record on September 18, 2014