Therapeutic Magnetic Resonance Imaging (MRI)-Guided High Intensity Focused Ultrasound (HIFU) Ablation of Uterine Fibroids

Summary

This study is to confirm the safety and technical effectiveness of MRI guided High Intensity Focused Ultrasound (HIFU) in ablating uterine tissue associated with symptomatic leiomyomas. The importance of this therapy is that it offers a non-invasive, uterine sparing procedure for the treatment of uterine fibroids in pre- and peri- menopausal women.

MRI guided high intensity focused ultrasound uses ultrasound to heat and thermally ablate fibroid tissue. The MRI system identifies the ultrasound path and monitors heat rise in the fibroid tissue. The goal of the study is to show treatment safety and technical effectiveness. MR-guided HIFU will be performed in patients who pass inclusion/exclusion criteria. Safety, quality of life, and imaging endpoints will be evaluated in all study patients.

The goal of this study is to demonstrate that:

1. The safety profile is acceptable (safety)
2. Actual MR-HIFU ablated volumes (as measured with contrast enhanced MRI) match the intended volumes (technical effectiveness)
3. When intended, volumes greater than 20% of the fibroid volume can be successfully ablated (technical effectiveness)

The investigators' hypothesis is that greater than 70% of fibroids will have concordance between intended lesion volume and actual lesion volume while maintaining an acceptable safety profile.

Conditions

• Uterine Fibroids

Interventions

DEVICE

Philips MRI-guided HIFU system

HIFU is the use of focused ultrasound energy to penetrate through soft tissue and causes localized high temperatures (55°C to 70°C) for a few seconds within the target producing well defined regions of protein denaturation, irreversible cell damage, and coagulative necrosis.

Sponsors & Collaborators

• Philips Medical Systems

  collaborator INDUSTRY

• Philips Healthcare

  lead INDUSTRY

Principal Investigators

• Herve Trillaud, Prof, MD · Hospital St. Andre, Bordeaux, France

• Lim Hyo Keun, MD · Samsung Medical Center, Seoul, Korea

• Willem Mali, Prof, MD · University Medical Center - Utrecht, Netherlands

• Joerg Barkhausen, Prof, MD · University Hospital Schleswig-Holstein, Lübeck, Germany

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

59 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-04-30

Primary Completion

2009-12-31

Completion

2009-12-31

Countries

• France
• Germany
• Netherlands
• South Korea

Study Locations