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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00897897
Recruitment Status : Completed
First Posted : May 12, 2009
Results First Posted : November 11, 2011
Last Update Posted : December 4, 2012
Philips Medical Systems
Information provided by (Responsible Party):
Philips Healthcare

Brief 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.

Condition or disease Intervention/treatment Phase
Uterine Fibroids Device: Philips MRI-guided HIFU system Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial Protocol for Therapeutic MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids
Study Start Date : April 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Treated leiomyomas
Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure receive a treatment with the Philips MRI-guided HIFU system. Patients must have completed child bearing prior to enrolling in this study.
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.
Other Name: Sonalleve

Primary Outcome Measures :
  1. Adverse Events/Subject Resulting From HIFU Treatment of the Uterine Fibroids [ Time Frame: 30 days after treatment ]
    The number of Adverse Events reported during the study, divided by the total number of treated subjects. This corresponds to the mean number of Adverse Events per subject.

Secondary Outcome Measures :
  1. Fibroid Symptom Severity Score (SSS) From the Uterine Fibroid Symptoms - Quality of Life (UFS-QoL) Questionnaire. [ Time Frame: At baseline and at 30 days following treatment ]

    Mean absolute change in the Symptom Severity Score (SSS) of the Uterine Fibroid Symptoms - Quality of Life (UFS-QoL) questionnaire after fibroid treatment with HIFU.

    The SSS is a scale from 0-100, where 0 corresponds to no symptoms and 100 corresponds to the most severe symptoms.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Women, age between 18 and 59 years
  • Weight < 140kg
  • Pre- or peri-menopausal
  • Uterine size < 24 weeks
  • Transformed SSS score > 40
  • Normal Cervical cell assessment by PAP
  • Symptomatic Fibroid disease
  • Dominant fibroid greater than or equal to 3cm and less than or equal to 12 cm

Exclusion Criteria:

  • Other Pelvic Disease
  • Desire for future pregnancy
  • Significant systemic disease even if controlled
  • Positive pregnancy test
  • Hematocrit < 25%
  • Scarring or other interference of the HIFU beam
  • MRI or contrast contraindicated
  • Fibroids not quantifiable on MRI
  • Calcifications around or throughout uterine tissues
  • Communication barrier

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00897897

Hospital St. Andre
Bordeaux, France
University Hospital Schleswig-Holstein
Lübeck, Germany
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
University Medical Center
Utrecht, Netherlands
Sponsors and Collaborators
Philips Healthcare
Philips Medical Systems
Principal Investigator: Herve Trillaud, Prof, MD Hospital St. Andre, Bordeaux, France
Principal Investigator: Lim Hyo Keun, MD Samsung Medical Center, Seoul, Korea
Principal Investigator: Willem Mali, Prof, MD University Medical Center - Utrecht, Netherlands
Principal Investigator: Joerg Barkhausen, Prof, MD University Hospital Schleswig-Holstein, Lübeck, Germany


Responsible Party: Philips Healthcare Identifier: NCT00897897     History of Changes
Other Study ID Numbers: 996233
First Posted: May 12, 2009    Key Record Dates
Results First Posted: November 11, 2011
Last Update Posted: December 4, 2012
Last Verified: December 2012

Keywords provided by Philips Healthcare:
Uterine Leiomyomas
High Intensity Focused Ultrasound

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases