Magnetic Resonance Elastography (MRE) of Uterine Fibroids

NCT01229826 | Completed

• 2 other identifiers: 10-002112Mayo Clinic
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Fibroids

Keywords

Uterine fibroids; Uterine leiomyomas; MR Elastography; MRI (Magnetic Resonance Imaging); Symptomatic Uterine Fibroids

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Examination of Magnetic Resonance Elastography stiffness values and MR T2.

  every six months

Interventions

MR Elastography RADIATION

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.

Also known as: Signa, GE Healthcare

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Women able to give informed consent
• Women having uterine imaging

You may not qualify if:

• Women currently pregnant
• Allergy to either gadolinium or iodinated contrast
• Severe claustrophobia
• Weight in excess of 250 pounds

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Leiomyoma; Myofibroma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• David A. Woodrum, M.D., PhD.

  Mayo Clinic - Rochester, Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: David A. Woodrum, M.D., PhD.

Study Record Dates

• First Submitted: October 22, 2010
• First Posted: October 28, 2010
• Study Start: October 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 2, 2015

Record last verified: 2015-09

Locations

US (1)