Magnetic Resonance Elastography (MRE) of Uterine Fibroids

Uterine Fibroids Clinical Trial

— MRE  

Official title:

Magnetic Resonance Elastography (MRE) of Uterine Fibroids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01229826
• Other study ID #: 10-002112
• Secondary ID: Mayo Clinic
• Status: Completed
• Phase: N/A
• First received: October 22, 2010
• Last updated: September 1, 2015
• Start date: October 2010
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acquisition of MR elastography images for comparison.	MRE is performed at the end of the examination after the standard Magnetic Resonance Imaging(MRI) protocol.	every six months	No
Secondary	Examination of Magnetic Resonance Elastography stiffness values and MR T2.	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	No