Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids

Not Applicable

Completed

• Conditions: Uterine Fibroids
• Interventions: Procedure: Placebo MR Guided Focused Ultrasound; Procedure: MR Guided Focused Ultrasound

• Registration Number: NCT01377519
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-15
• Study First Submitted QC: 2011-06-17
• Study First Posted: 2011-06-21
• Primary Completion: 2012-09
• Study Completion: 2012-12
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-04
• Last Update Posted: 2019-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo MR Guided Focused Ultrasound	Placebo MR Guided Focused Ultrasound	-
MR Guided Focused Ultrasound	MR Guided Focused Ultrasound	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States