Clinical Trials

Uterine fibroids affect up to 70 to 80% of women and about 30% of women are symptomatic. Over 200,000 hysterectomies are performed each year for uterine fibroids in the USA. The direct health care costs attributable to uterine fibroids exceed $2.1 billion annually. Fibroids are reported to cause a number of symptoms including heavy or prolonged menstrual bleeding, pelvic pressure, pain with menses and bowel and bladder dysfunction. However, fibroid symptomatology is incompletely understood. Understanding and addressing the myomas pain are important in optimizing treatment outcomes and controlling health care costs from a societal perspective. This study proposes to optimally characterize symptoms and symptom relief in women with leiomyomas severe enough to seek interventional therapy. Secondly we will characterize a variety of symptoms utilizing standardized instruments for other pelvic diseases and symptoms to optimize comparisons with other disease processes. Clinical and scientific significance of the studies is high. We look to generate resources which can be used at a later time to assess the biologic and genetic variables affecting treatment outcome and to comprehensively assess the societal economic impact of uterine fibroids and their treatment with UAE and MRgFUS. Participants will be in the study for up to 36 months following fibroid treatment.

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.