Magnetic Resonance Elastography (MRE) of Uterine Fibroids (MRE)

September 1, 2015 updated by: David A. Woodrum, Mayo Clinic

The purpose of this study is to gain additional information regarding use of Magnetic Resonance Elastography (MRE) for uterine fibroid characterization. In this study, the investigators will use a new noninvasive technology, MRE, to further characterize the elastic properties of the uterine fibroids. To date, very little is known concerning how the tissue composition of the uterine fibroid may affect its treatment with Magnetic Resonance Guided Focused Ultrasound (MRgFUS).

In this study, the investigators will use a new noninvasive technology, magnetic resonance elastography (MRE), to further characterize the elastic properties of the uterine fibroids. This information will be gathered during routine magnetic resonance imaging for symptomatic uterine fibroids. It is known that some fibroids with increased T2-signal on Magnetic Resonance Imaging(MRI) can be more difficult to treat.

This information will be gathered during routine magnetic resonance imaging for symptomatic uterine fibroids.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a single-site, non-randomized pilot study to determine whether Magnetic Resonance Elastography (MRE) can be optimized for clinical use as part of the patients routine clinical imaging and to correlate with MR signal characteristics of the uterine fibroid.

MRE is performed at the end of the examination after the standard Magnetic Resonance Imaging protocol.

Aims:

Specific Aim 1: To acquire magnetic resonance elastography images on women who have a clinically ordered pelvic magnetic resonance imaging (MRI) for uterine fibroids.

Specific Aim 2: To examine the correlation between MRE stiffness values and MR T2 signal characteristics for uterine fibroids. For a subset of patients going on to surgery correlation with pathology can also be performed.

This study will seek to determine whether MRE can be performed in the pelvis on a routine clinical basis as well as correlating the MRE findings with magnetic resonance signal characteristics. There are no additional risks to the patient and no additional cost to the MRI exam.

Study Type

Observational

Enrollment (Actual)

134

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female individuals between the years of 18 and 65 whose doctor has suggested magentic resonance imaging of the uterus for treatment of uterine fibroids.

Description

Inclusion Criteria:

  1. Women able to give informed consent
  2. Women having uterine imaging

Exclusion Criteria:

  1. Women currently pregnant
  2. Allergy to either gadolinium or iodinated contrast
  3. Severe claustrophobia
  4. Weight in excess of 250 pounds

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acquisition of MR elastography images for comparison.
Time Frame: every six months
MRE is performed at the end of the examination after the standard Magnetic Resonance Imaging(MRI) protocol.
every six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Examination of Magnetic Resonance Elastography stiffness values and MR T2.
Time Frame: every six months
To examine the correlation between MR elastography stiffness values and MR T2 signal characteristics for uterine fibroids. For a subset of patients going on to surgery correlation with pathology can also be performed.
every six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: David A. Woodrum, M.D., PhD., Mayo Clinic - Rochester, Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

October 22, 2010

First Submitted That Met QC Criteria

October 27, 2010

First Posted (Estimate)

October 28, 2010

Study Record Updates

Last Update Posted (Estimate)

September 2, 2015

Last Update Submitted That Met QC Criteria

September 1, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-002112
  • Mayo Clinic (Other Identifier: Internal Funding)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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