PROMISe: Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT01377519

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Fibroids	Procedure: MR Guided Focused Ultrasound Procedure: Placebo MR Guided Focused Ultrasound	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Magnetic Resonance-Guided Focused Ultrasound to Treat Uterine Fibroids: A Pilot Randomized, Placebo-Controlled Trial

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: MR Guided Focused Ultrasound	Procedure: MR Guided Focused Ultrasound This is an FDA approved noninvasive treatment for fibroids that uses highly focused ultrasound waves to damage fibroid tissue.
Placebo Comparator: Placebo MR Guided Focused Ultrasound	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.

Arm

Intervention/Treatment

Active Comparator: MR Guided Focused Ultrasound

Procedure: MR Guided Focused Ultrasound

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

Placebo Comparator: Placebo MR Guided Focused Ultrasound

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.

Outcome Measures

Primary Outcome Measures

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]