Clinical trial NCT01229826: Magnetic Resonance Elastography (MRE) of Uterine Fibroids
Official title: Magnetic Resonance Elastography (MRE) of Uterine Fibroids
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Fibroids
Keywords: Uterine fibroids
Uterine leiomyomas
MR Elastography
MRI (Magnetic Resonance Imaging)
Symptomatic Uterine Fibroids
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-10-28
Enrollment: 134
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Acquisition of MR elastography images for comparison.
timeFrame: every six months
Secondary outcomes:
measure: Examination of Magnetic Resonance Elastography stiffness values and MR T2.
timeFrame: every six months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic - Rochester, Minnesota
name: David A. Woodrum, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References: