NCT01141062

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

December 4, 2012

Status Verified

December 1, 2012

Enrollment Period

1.3 years

First QC Date

June 8, 2010

Last Update Submit

December 3, 2012

Conditions

Uterine Leiomyomas

Keywords

Uterine Fibroids

Outcome Measures

Primary Outcomes (2)

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

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

    Day of treatment, 24, 48, 72 hrs, 1 and 2 wks and 30 days after treatment

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

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

    Day of treatment, 30 days after treatment

Secondary Outcomes (3)

  • Change in Quality of Life Scores

    0, 30 days

  • Pain score

    0, 24, 48, 72 hours and 1 and 2 weeks, and 30 days

  • Timeframe before returning to daily activities

    0, 24, 48, 72 hours and 1 and 2 weeks, and 30 days

Study Arms (1)

Treated leiomyomas

EXPERIMENTAL

Philips MR-guided HIFU

Device: Philips MR-guided HIFU

Interventions

Philips MR-guided HIFUDEVICE

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

Age18 Years - 59 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Sunnybrook Health Sciences Centre, University of Toronto

Toronto, Ontario, M4N 3M5, Canada

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: 11814511BACKGROUND

MeSH Terms

Conditions

MyofibromaLeiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue DiseasesSkin and Connective Tissue DiseasesNeoplasms, Muscle Tissue

Study Officials

  • Elizabeth David, MD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

  • Neety Panu, MD

    Thunder Bay Regional Health Sciences Centre

    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

June 8, 2010

First Posted

June 10, 2010

Study Start

June 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

December 4, 2012

Record last verified: 2012-12

Locations

CA(2)