Mayo Clinic and Duke University are conducting the first study to compare uterine artery embolization (UAE) and MR-guided focused ultrasound (MRgFUS) for the treatment of uterine fibroids.
The study, called Fibroid Interventions: Reducing Symptoms Today and Tomorrow (FIRSTT), will randomly assign women to be treated with either UAE or MRgFUS. The study will follow patients for three years to assess how effective the treatments are in symptom relief, absence of side effects,impact on quality of life, need for additional treatment, and even the costs associated with each approach.
The primary goal of this study is to compare the safety and effectiveness of two standard fibroid treatments: MRI guided ultrasound surgery (MRgFUS) and uterine artery embolization (UAE). Both treatments are approved by the Food and Drug Administration (FDA) for women who do not plan to become pregnant.A second goal of this study is to better understand which symptoms bother women with fibroids the most. Understanding and addressing the symptoms of clinically-significant uterine fibroids is important in order to optimize treatment outcomes and control health care costs.Women who are eligible to participate in the study, are randomized to one of two treatment arms (UAE or MRgFUS). Women in both arms will receive treatment but will not be able to choose which treatment she will receive.A comprehensive assessment of symptoms-including experienced pain- will take place at baseline, 6 weeks, and at 6, 12, 24, and 36 months following treatment with UAE and MRgFUS.
The study is now enrolling 220 women who can be treated at Mayo Clinic in Rochester, Minnesota or Duke University in Durham, North Carolina.
To find out more about the study and whether you are eligible to participate, please click here.
ExAblate UF V2 System for the Treatment of Symptomatic Uterine Fibroids
This study is recruiting patients
The purpose of this study is to evaluate the safety and ablation efficacy of the ExAblate UF V2 System when treating symptomatic uterine fibroids.
The ExAblate System is a medical device that involves a focused ultrasound system and an MRI scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the targeted tissue. In this particular study, the targeted tissue is uterine fibroids. Each sonication is used to heat small spots in the fibroid much like a magnifying glass can be used to focus light to heat a spot. The heat created kills a portion of the fibroid with the goal of decreasing or eliminating uterine fibroid-related symptoms. Repeated sonications are performed until the entire fibroid is treated or the treated volume is determined to be appropriate.
The ExAblate UF V2 System is an experimental device and is being investigated in this study. While similar to the commercial system, the ExAblate UF V2 device includes the following major changes, among others, which are intended to improve device performance and safety:
Up and down movement of the ultrasound transducer, in an attempt to improve fibroid treatment by moving the ultrasound focal point within the targeted fibroid. Ultrasound energy can be turned off for a specific area in an attempt to minimize amount of energy passing through sensitive areas of the body.
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Contact: Louise Greenberg 617-732-5441 LGREENBERG@PARTNERS.ORG
Principal Investigator: Serene Srouji, M.D.
This study is active but not recruiting patients
This is a pilot randomized, blinded, placebo-controlled trial of a noninvasive, FDA approved treatment for uterine fibroids called MR Guided Focused Ultrasound (MRgFUS). Our hypothesis is that MRgFUS provides superior relief of fibroid symptoms compared with the placebo, a sham MRgFUS treatment. The investigators will recruit 20 premenopausal women with symptomatic uterine fibroids to participate in the trial. Participants will be randomly assigned in a 2:1 ratio to the active treatment arm (MRgFUS) versus the sham MRgFUS treatment. Participants will remain blinded to their group assignment for 3 months. After 3 months, participants will be told their treatment group and those assigned to the sham group will be offered complimentary MRgFUS if they desire it. Women will be excluded if they are inappropriate candidates for a 3 month delay in fibroid treatment, such as those with significant anemia. The investigators will assess the change from baseline to 1 and 3 months after treatment in fibroid symptoms, quality of life, fibroid volume measured by MRI, and hematocrit.
Study Start Date: June 2011
Estimated Study Completion Date: Dec 2012
The study is taking place at the University of California, San Francisco.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01377519
For more information on this study and to check your eligibility, pleases contact:
University of California, San Francisco
San Francisco, California, United States, 94115
Contact: Shirley Wong 415-502-4082
Principal Investigator: Vanessa Jacoby, MD
Sub-Investigator: Fergus Coakley, MD