Magnetic Resonance Elastography (MRE) of Uterine Fibroids

NCT ID: NCT01229826

Last Updated: 2015-09-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 134 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2015-06-30

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.

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.

Conditions

Uterine Fibroids

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: RADIATION

Other Intervention Names

Signa; GE Healthcare

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

David A. Woodrum

David A. Woodrum, M.D., PhD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David A. Woodrum, M.D., PhD.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic - Rochester, Minnesota

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

Mayo Clinic

Identifier Type: OTHER

Identifier Source: secondary_id

10-002112

Identifier Type: -

Identifier Source: org_study_id