Therapeutic MRI-HIFU Ablation of Uterine Fibroids in a 3T MRI Scanner

NCT01064960 | Completed Phase 3 DMC

• 1 other identifier: 997677
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Uterine Leiomyomas

Keywords

Neoplasms, Connective and Soft Tissue; Neoplasms, Muscle Tissue; Neoplasms; Myofibroma; Neoplasms by Histologic Type; Connective Tissue Diseases; Neoplasms, Connective Tissue; Leiomyoma

Outcome Measures

Primary Outcomes (2)

• Safety of HIFU for treatment of the uterine fibroids as determined by adverse event reporting.

  Number of adverse events reported in the study divided by the total number of treated subjects.

  30 days after treatment

• Technical efficacy of HIFU for treatment of uterine fibroids as assessed by a change in the Symptom Severity Score

  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.

  30 days after treatment

Secondary Outcomes (3)

• Change in Quality of Life Scores

  30 days after treatment

• Pain score

  72 hours after treatment

• Timeframe before returning to daily activities

  72 hours after treatment

Study Arms (1)

Treated leiomyomas

EXPERIMENTAL

Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure are treated with the Philips MR-guided HIFU system. Patients must have completed child bearing prior to enrolling in this study.

Device: Philips MR-guided HIFU system

Interventions

Philips MR-guided HIFU system DEVICE

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.

Also known as: Sonalleve, Uterine Leiomyomas, Fibroids, HIFU, Ablation, High Intensity Focused Ultrasound

Treated leiomyomas

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philips Healthcare: lead
• Philips Medical Systems: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Related Publications (1)

• Spies JB, Coyne K, Guaou Guaou N, Boyle D, Skyrnarz-Murphy K, Gonzalves SM. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata. Obstet Gynecol. 2002 Feb;99(2):290-300. doi: 10.1016/s0029-7844(01)01702-1.

  PMID: 11814511 BACKGROUND

MeSH Terms

Conditions

Myofibroma; Neoplasms, Connective and Soft Tissue; Neoplasms, Muscle Tissue; Neoplasms; Neoplasms by Histologic Type; Connective Tissue Diseases; Neoplasms, Connective Tissue; Leiomyoma

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

• Erik Fosse, Professor

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2010
• First Posted: February 9, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: December 4, 2012

Record last verified: 2012-12

Locations

NO (1)