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What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography

Primary Purpose

Uterine Bleeding, Uterine Fibroids, Adenomyosis

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Evaluation of MRI, US for pelvic and uterine conditions
Patient preference between MRI and Ultrasound
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Uterine Bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 -

Sites / Locations

  • University of Michigan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Evaluation of MRI, US for pelvic conditions

Patient preference MRI vs. US

Arm 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.

We are asking subjects to evaluate patient preference between MRI (magnetic resonance imaging) and ultrasound to determine which they would rather undergo.

Outcomes

Primary Outcome Measures

Diagnostic accuracy of MRI and ultrasound elastography for distinguishing adenomyosis and fibroids
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
Patients will take a survey to assess their experiences and preferences for pelvic imaging tests within 6 months after having those tests

Full Information

First Posted
November 7, 2013
Last Updated
May 30, 2018
Sponsor
University of Michigan
Collaborators
Association of University Radiologists, GE Radiology Research Academic Fellowship
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1. Study Identification

Unique Protocol Identification Number
NCT01992718
Brief Title
What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography
Official Title
What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 2013 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Association of University Radiologists, GE Radiology Research Academic Fellowship

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Bleeding, Uterine Fibroids, Adenomyosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evaluation of MRI, US for pelvic conditions
Arm Type
Active Comparator
Arm 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.
Arm Title
Patient preference MRI vs. US
Arm Type
Active Comparator
Arm Description
We are asking subjects to evaluate patient preference between MRI (magnetic resonance imaging) and ultrasound to determine which they would rather undergo.
Intervention Type
Procedure
Intervention Name(s)
Evaluation of MRI, US for pelvic and uterine conditions
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Patient preference between MRI and Ultrasound
Intervention Description
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 Outcome Measure Information:
Title
Diagnostic accuracy of MRI and ultrasound elastography for distinguishing adenomyosis and fibroids
Description
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
Time Frame
1-2 months per patient
Secondary Outcome Measure Information:
Title
Patient preference between ultrasound and MRI
Description
Patients will take a survey to assess their experiences and preferences for pelvic imaging tests within 6 months after having those tests
Time Frame
6 months per patient

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Maturen, MD, MS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography

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