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Magnetic Resonance Elastography (MRE) of Uterine Fibroids

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Mayo Clinic
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01229826
First received: October 22, 2010
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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 Intervention
Uterine Fibroids
Radiation: MR Elastography

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Magnetic Resonance Elastography (MRE) of Uterine Fibroids

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Acquisition of MR elastography images for comparison. [ Time Frame: every six months ] [ Designated as safety issue: No ]
    MRE is performed at the end of the examination after the standard Magnetic Resonance Imaging(MRI) protocol.


Secondary Outcome Measures:
  • Examination of Magnetic Resonance Elastography stiffness values and MR T2. [ Time Frame: every six months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: October 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
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: NCT01229826

Contacts
Contact: Lisa G. Peterson, BSN, RN 507-266-4813 mayofibroids@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Connie L. Sathre    507-538-0540    mayofibroids@mayo.edu   
Principal Investigator: David A. Woodrum, M.D., PhD.         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: David A. Woodrum, M.D., PhD. Mayo Clinic-Rochester, Minnesota
  More Information

No publications provided

Responsible Party: David A. Woodrum, M.D., PhD., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01229826     History of Changes
Other Study ID Numbers: 10-002112, Mayo Clinic
Study First Received: October 22, 2010
Last Updated: August 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Uterine fibroids
Uterine leiomyomas
MR Elastography
MRI (Magnetic Resonance Imaging)
Symptomatic Uterine Fibroids

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

ClinicalTrials.gov processed this record on November 20, 2014