Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Uterine Fibroids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MR Guided Focused Ultrasound

Group Type ACTIVE_COMPARATOR

MR Guided Focused Ultrasound

Intervention Type PROCEDURE

This is an FDA approved noninvasive treatment for fibroids that uses highly focused ultrasound waves to damage fibroid tissue.

Placebo MR Guided Focused Ultrasound

Group Type PLACEBO_COMPARATOR

Placebo MR Guided Focused Ultrasound

Intervention Type PROCEDURE

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.

Interventions

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MR Guided Focused Ultrasound

This is an FDA approved noninvasive treatment for fibroids that uses highly focused ultrasound waves to damage fibroid tissue.

Intervention Type PROCEDURE

Placebo 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No