Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids

Study Overview
=================
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.

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

Conditions
-----------------
Uterine Fibroids

Intervention / Treatment
-----------------
* Procedure: MR Guided Focused Ultrasound
* Procedure: Placebo MR Guided Focused Ultrasound


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIFU, Fibroids, Uterine, Focused Ultrasound, Magnetic Resonance focused ultrasound, NOninvasive, Treatment