Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids

Uterine Fibroids Clinical Trial

— PROMISe  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01377519
• Other study ID #: 001
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: December 2012

Study information

• Verified date: November 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

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 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.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibroid volume measured on MRI		Change from baseline prior to treatment until 3 months after treatment
Primary	Fibroid symptoms reported by participant		Change from baseline prior to treatment to 1 and 3 months after treatment
Primary	Red blood cell count (hematocrit)		Change from baseline prior to treatment and 3 months after treatment

External Links

•   Fibroid trials at UCSF