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What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography

NCT01992718 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2018-05-31

No results posted yet for this study

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).

Conditions

  • Uterine Bleeding
  • Uterine Fibroids
  • Adenomyosis

Interventions

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.

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.

Sponsors & Collaborators

  • Association of University Radiologists

    collaborator UNKNOWN

  • GE Radiology Research Academic Fellowship

    collaborator UNKNOWN

  • University of Michigan

    lead OTHER

Principal Investigators

  • Katherine Maturen, MD, MS · University of Michigan

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01992718 on ClinicalTrials.gov