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
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|
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.
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|
|Actual Enrollment :||134 participants|
|Official Title:||Magnetic Resonance Elastography (MRE) of Uterine Fibroids|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
- 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:
- GE Healthcare
- 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.
- 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.
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
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||David A. Woodrum, M.D., PhD.||Mayo Clinic - Rochester, Minnesota|