Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids

Completed · Not applicable · Has a placebo group

Conditions studied: Uterine Fibroids

In brief

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.

Key facts

Study ID

NCT01377519

Run by

University of California, San Francisco

People needed

20

Starts

2011-06-01

Expected to finish

2012-12-01

Last updated by the study team

2019-11-05

Who can join

Age: 18 and older, up to 99. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age>18 years
• Premenopausal
• Symptomatic fibroids
• Fibroids accessible for focused ultrasound treatment

You may not qualify if…

• Desires future fertility
• Current pregnancy
• Hematocrit <30%
• Emergency room visit in last 3 months for fibroid symptoms
• History of venous thromboembolism
• Fibroids that are: >10cm, non-enhancing with contrast
• Adenomyosis
• Contraindications to undergoing MRI
• Unexplained menstrual irregularity

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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