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

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ClinicalTrials.gov Identifier: NCT01229826
Recruitment Status : Completed
First Posted : October 28, 2010
Last Update Posted : September 2, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Uterine Fibroids Radiation: MR Elastography

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 Design

Study Type : Observational
Actual Enrollment : 134 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Magnetic Resonance Elastography (MRE) of Uterine Fibroids
Study Start Date : October 2010
Primary Completion Date : June 2015
Study Completion Date : June 2015
Groups and Cohorts

Intervention Details:
    Radiation: MR Elastography
    MRE is performed at the end of the examination after the standard MRI protocol. A test vibration is first applied on the patient to familiarize the patient with the vibration. The MRE sequence is performed with either a body coil or a pelvic-array coil. The total acquisition time is split into four periods of suspended respiration of 16 seconds for acquisition of wave images at four phase offsets. To obtain a consistent position of the fibroid for each phase offset, patients are asked to quietly breath and remain still.
    Other Names:
    • Signa
    • GE Healthcare

Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01229826


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: David A. Woodrum, M.D., PhD. Mayo Clinic - Rochester, Minnesota
More Information

Responsible Party: David A. Woodrum, David A. Woodrum, M.D., PhD., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01229826     History of Changes
Other Study ID Numbers: 10-002112
Mayo Clinic ( Other Identifier: Internal Funding )
First Posted: October 28, 2010    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: September 2015

Keywords provided by David A. Woodrum, Mayo Clinic:
Uterine fibroids
Uterine leiomyomas
MR Elastography
MRI (Magnetic Resonance Imaging)
Symptomatic Uterine Fibroids

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases