Text Size

Clinical Trial Protocol for Therapeutic MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids in a 3T MRI Scanner

This study has been completed.
Sponsor:
Collaborator:
Philips Medical Systems
Information provided by (Responsible Party):
Philips Healthcare
ClinicalTrials.gov Identifier:
NCT01064960
First received: February 5, 2010
Last updated: February 17, 2012
Last verified: February 2012
History of Changes
  Purpose

This study is to collect supplementary safety and technical effectiveness data of Philips MRI guided High Intensity Focused Ultrasound (HIFU) in ablating uterine tissue associated with symptomatic fibroids in a 3T MRI scanner. 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 collect supplementary 3T treatment safety and technical effectiveness data in a 1 month follow-up study. MRguided 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.


Condition Intervention Phase
Uterine Leiomyomas
 Device: Philips MR-guided HIFU system
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Trial Protocol for Therapeutic MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids in a 3T MRI Scanner

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Philips Healthcare:

Primary Outcome Measures:
  • Safety of HIFU for treatment of the uterine fibroids as determined by adverse event reporting. [ Time Frame: 30 days after treatment ] [ Designated as safety issue: Yes ]
    Number of adverse events reported in the study divided by the total number of treated subjects.

  • Technical efficacy of HIFU for treatment of uterine fibroids as assessed by a change in the Symptom Severity Score [ Time Frame: 30 days after treatment ] [ Designated as safety issue: No ]
    Mean absolute change in the Symptom Severity Score (SSS) of the uterine Fibroid Symptoms Quality of Life questionnaire from baseline to 30 days after treatment.


Secondary Outcome Measures:
  • Change in Quality of Life Scores [ Time Frame: 30 days after treatment ] [ Designated as safety issue: No ]
    Mean absolute score change in the Quality of Life questionnaire from baseline to 30 days after treatment.

  • Pain score [ Time Frame: 72 hours after treatment ] [ Designated as safety issue: No ]
    Mean Visual Analog Score (VAS) for pain 72 hours after treatment.

  • Timeframe before returning to daily activities [ Time Frame: 72 hours after treatment ] [ Designated as safety issue: No ]
    Mean timeframe for the patient to return to normal activity after treatment.


Enrollment: 7
Study Start Date: January 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treated leiomyomas
Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have completed child bearing prior to enrolling in this study.
 Device: Philips MR-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 Names:
  • Uterine Leiomyomas
  • Fibroids
  • HIFU
  • Ablation
  • High Intensity Focused Ultrasound

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01064960

Locations
Norway
Oslo University Hospital
Oslo, Norway
Sponsors and Collaborators
Philips Healthcare
Philips Medical Systems
Investigators
Principal Investigator: Erik Fosse, Professor Oslo University Hospital
  More Information

Publications:

Responsible Party: Philips Healthcare
ClinicalTrials.gov Identifier: NCT01064960     History of Changes
Other Study ID Numbers: 997677
Study First Received: February 5, 2010
Last Updated: February 17, 2012
Health Authority: Norway: Directorate of Health

Keywords provided by Philips Healthcare:
Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue
Neoplasms
Myofibroma
 Neoplasms by Histologic Type
Connective Tissue Diseases
Neoplasms, Connective Tissue
Leiomyoma

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

ClinicalTrials.gov processed this record on October 17, 2012