Clinical trial NCT01377519: Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids
Official title: Magnetic Resonance-Guided Focused Ultrasound to Treat Uterine Fibroids: A Pilot Randomized, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Fibroids
Keywords: Fibroids
Uterine
Focused Ultrasound
Magnetic Resonance focused ultrasound
HIFU
NOninvasive
Treatment
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2011-06-21
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Fibroid volume measured on MRI
timeFrame: Change from baseline prior to treatment until 3 months after treatment
measure: Fibroid symptoms reported by participant
timeFrame: Change from baseline prior to treatment to 1 and 3 months after treatment
measure: Red blood cell count (hematocrit)
timeFrame: Change from baseline prior to treatment and 3 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Vanessa Jacoby, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jacoby VL, Kohi MP, Poder L, Jacoby A, Lager J, Schembri M, Rieke V, Grady D, Vittinghoff E, Coakley FV. PROMISe trial: a pilot, randomized, placebo-controlled trial of magnetic resonance guided focused ultrasound for uterine fibroids. Fertil Steril. 2016 Mar;105(3):773-780. doi: 10.1016/j.fertnstert.2015.11.014. Epub 2015 Dec 1.