Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids
Status: | Completed |
---|---|
Conditions: | Cervical Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 9/23/2012 |
Start Date: | June 2011 |
End Date: | July 2012 |
Contact: | Shirley Wong |
Phone: | 415.502-4082 |
Magnetic Resonance-Guided Focused Ultrasound to Treat Uterine Fibroids: A Pilot Randomized, Placebo-Controlled Trial
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.
Inclusion Criteria:
- Age>18 years
- Premenopausal
- Symptomatic fibroids
- Fibroids accessible for focused ultrasound treatment
Exclusion criteria:
- 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
We found this trial at
1
site
500 Parnassus Ave
San Francisco, California 94110
San Francisco, California 94110
(415) 476-9000
University of California, San Francisco UCSF's clinical enterprise is recognized nationally for its leading health...
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