Uterine Fibroids
Conditions
Keywords
Fibroids, Uterine, Focused Ultrasound, Magnetic Resonance focused ultrasound, HIFU, NOninvasive, Treatment
Brief summary
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.
Interventions
PROCEDUREMR Guided Focused Ultrasound
This is an FDA approved noninvasive treatment for fibroids that uses highly focused ultrasound waves to damage fibroid tissue.
PROCEDUREPlacebo MR Guided Focused Ultrasound
This is a placebo treatment that requires a participant to undergo identical procedures as those of the actual MR Guided Focused Ultrasound procedure, but higly focused ultrasound waves are not directed at the uterine fibroid.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fibroid volume measured on MRI | Change from baseline prior to treatment until 3 months after treatment |
| Fibroid symptoms reported by participant | Change from baseline prior to treatment to 1 and 3 months after treatment |
| Red blood cell count (hematocrit) | Change from baseline prior to treatment and 3 months after treatment |
Countries
United States
Outcome results
None listed