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

Primary Purpose

Uterine Leiomyomas

Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Philips MR-guided HIFU system
Sponsored by
Philips Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Leiomyomas focused on measuring Neoplasms, Connective and Soft Tissue, Neoplasms, Muscle Tissue, Neoplasms, Myofibroma, Neoplasms by Histologic Type, Connective Tissue Diseases, Neoplasms, Connective Tissue, Leiomyoma

Eligibility Criteria

18 Years - 59 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Oslo University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treated leiomyomas

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Change in Quality of Life Scores
Mean absolute score change in the Quality of Life questionnaire from baseline to 30 days after treatment.
Pain score
Mean Visual Analog Score (VAS) for pain 72 hours after treatment.
Timeframe before returning to daily activities
Mean timeframe for the patient to return to normal activity after treatment.

Full Information

First Posted
February 5, 2010
Last Updated
December 3, 2012
Sponsor
Philips Healthcare
Collaborators
Philips Medical Systems
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1. Study Identification

Unique Protocol Identification Number
NCT01064960
Brief Title
Therapeutic MRI-HIFU Ablation of Uterine Fibroids in a 3T MRI Scanner
Official Title
Clinical Trial Protocol for Therapeutic MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids in a 3T MRI Scanner
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Healthcare
Collaborators
Philips Medical Systems

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Fibroids occur in 20-50% of women over 30 years of age, and with increasing size produce pain, menorrhagia, pressure, bloating and urinary and bowel compression symptoms. Fibroids may also cause infertility. Uterine leiomyomas are benign tumors originating from smooth muscle cells of the uterus and occasionally the smooth muscle of uterine blood vessels. Fibroids are estrogen dependent tumors ranging in size and number and can be found within the myometrium(intramural), at the uterine periphery extending to the serosa (subserosal), or pushing into the uterine cavity (submucosal). Symptomatic fibroids impact health and well-being of the female including lost work hours and reduced quality of life. Current medical treatments include invasive removal of the fibroid (hysterectomy, myomectomy), drug therapy (GnRH analogues or progestin compounds) or treatments causing necrosis of the fibroid tissue such as ablation (freezing or heating) or embolization. For the relief of symptoms, women wishing to preserve the uterus may choose between invasive procedures of myomectomy, Uterine Artery Embolization (UAE), ablation or cryotherapy. The surgically invasive procedures require anesthesia, hospital stays, and long recovery periods. HIFU may offer an alternative to the above mentioned surgically invasive procedures. In MRI-guided High Intensity Focused Ultrasound (HIFU), the ultrasound generated by the transducer is focused into a small focal tissue volume at specific target locations. During treatment, the beam of focused ultrasound energy penetrates 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. The MRI system allows 3D planning, means of measuring the temperature increase generated by HIFU, and the capability to quantifying the energy/dose delivered to the treatment zone. This study is a single-center, single arm, non-randomized trial evaluating the safety, technical effectiveness and volume treatment capabilities of the Philips MR-guided HIFU system in the treatment of symptomatic uterine fibroid patients. Patients who have symptomatic uterine fibroids, who are eligible according to the inclusion and exclusion criteria and provide informed consent will be enrolled in this study. It is anticipated that women will participate in the study for a 2month period to include the screening, HIFU treatment and post treatment follow-up. This clinical study is designed to confirm safety and demonstrate technical effectiveness of the Philips HIFU system for Uterine Fibroid treatment. Safety will be primarily assessed by evaluating minor complications and adverse events, and technical effectiveness will primarily be assessed with MRI measurements. Specific primary and secondary endpoints are detailed below. The study will use a combination of three primary endpoints: MR imaging of ablated volumes and minor complications/adverse events analysis to establish the safety and technical effectiveness of the Philips MR-HIFU system. These endpoints will determine the trial success. The treatment capabilities and technical effectiveness of the Philips MR-guided HIFU system will be assessed by (measurement type is noted in parentheses) Comparing the actual MR-measured ablated volumes to MR thermal dose predicted volumes Safety of the Philips MR-guided HIFU system will be demonstrated by Evaluating any minor complications or adverse events that result from the MR-guided HIFU treatment Verifying with MR imaging that no unintended lesions are formed as a result of the Treatment In addition, the following endpoints will be collected to supplement the primary outcomes: Pain and discomfort scores before, during and after treatment: These endpoints will be recorded using a 10-point visual analog scale for pain 4-point scale for discomfort. Return to Activity: This duration in days will be determined by the time after which the patients return to work (i.e. days after leaving the hospital) or to the usual activities for those not employed. Length of Hospital Stay (LOS): This duration in hours will be measured from the time the patient will arrive to the hospital until she will leave the hospital. Quality of Life questionnaires: the SF-36(http://www.sf36.org/tools/SF36.shtml) and UFS-QoL (which includes SSS)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Leiomyomas
Keywords
Neoplasms, Connective and Soft Tissue, Neoplasms, Muscle Tissue, Neoplasms, Myofibroma, Neoplasms by Histologic Type, Connective Tissue Diseases, Neoplasms, Connective Tissue, Leiomyoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treated leiomyomas
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Philips MR-guided HIFU system
Other Intervention Name(s)
Sonalleve, Uterine Leiomyomas, Fibroids, HIFU, Ablation, High Intensity Focused Ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety of HIFU for treatment of the uterine fibroids as determined by adverse event reporting.
Description
Number of adverse events reported in the study divided by the total number of treated subjects.
Time Frame
30 days after treatment
Title
Technical efficacy of HIFU for treatment of uterine fibroids as assessed by a change in the Symptom Severity Score
Description
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.
Time Frame
30 days after treatment
Secondary Outcome Measure Information:
Title
Change in Quality of Life Scores
Description
Mean absolute score change in the Quality of Life questionnaire from baseline to 30 days after treatment.
Time Frame
30 days after treatment
Title
Pain score
Description
Mean Visual Analog Score (VAS) for pain 72 hours after treatment.
Time Frame
72 hours after treatment
Title
Timeframe before returning to daily activities
Description
Mean timeframe for the patient to return to normal activity after treatment.
Time Frame
72 hours after treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Fosse, Professor
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
11814511
Citation
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.
Results Reference
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Therapeutic MRI-HIFU Ablation of Uterine Fibroids in a 3T MRI Scanner

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