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Sonalleve Fibroid Ablation Pivotal Clinical Trial for MR-HIFU of Uterine Fibroids (SOFIA)

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ClinicalTrials.gov Identifier: NCT01504308
Recruitment Status : Terminated (It was not possible to enroll patients into the study in a realistic timeframe.)
First Posted : January 5, 2012
Last Update Posted : April 5, 2017
Information provided by (Responsible Party):
Philips Healthcare

Brief Summary:
The purpose of this clinical study is to determine whether treatment with the Philips Sonalleve Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU) system is effective in the treatment symptomatic uterine leiomyomas (uterine fibroids).

Condition or disease Intervention/treatment Phase
Uterine Fibroids Device: MR-HIFU treatment Device: Sham treatment Phase 2 Phase 3

Detailed Description:

Uterine Fibroids are the most common benign tumors in pre- and peri-menopausal women. Fibroids occur in 20-50% of women over 30 years of age, and with increasing size can produce pain, menorrhagia, pressure, bloating and urinary and bowel compression symptoms. Fibroids may also cause infertility. 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, or treatments causing necrosis of the fibroid tissue such as ablation (freezing or heating) or embolization. It has been estimated that 600,000 hysterectomies are performed per year in the United States and more than half of the conducted hysterectomies are due to fibroids. 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. However, High Intensity Focused Ultrasound (HIFU) shows promising results in relieving fibroid symptoms.

This study will confirm the safety and clinical effectiveness of Philips Sonalleve MR-HIFU Fibroid Therapy system for ablating symptomatic fibroids.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Philips Pivotal Clinical Trial for MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids
Study Start Date : May 2012
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Experimental: MR-HIFU treatment
Patients receiving MR-HIFU treatment
Device: MR-HIFU treatment
A treatment session with the Philips Sonalleve MR-HIFU device for thermal ablation of uterine fibroids with high-intensity focused ultrasound.
Other Name: Philips Sonalleve MR-HIFU Uterine Fibroid Therapy

Sham Comparator: Sham Treatment
Patients receiving sham treatment
Device: Sham treatment
A pretend treatment session with the Philips Sonalleve MR-HIFU system in which no therapeutic ultrasound doses are delivered.
Other Name: pretend treatment with Philips Sonalleve MR-HIFU

Primary Outcome Measures :
  1. Alternative Interventional Treatment (AIT) [ Time Frame: 12 months after HIFU treatment ]

    AIT is scored dichotomously as follows:

    0 = Failure. Failure occurs if an AIT for fibroid related symptoms is administered within 12 months of study treatment.

    1 = Success. Success occurs if no AIT is administered for fibroid related symptoms within 12 months of study treatment.

    An AIT is defined as being one of the following: hysterectomy, myomectomy, uterine artery embolization, endometrial ablation and resection, or another MR-HIFU treatment (with the exception of a 're-treatment' as defined in the protocol, e.g. because of temporarily inaccessible fibroids).

  2. Menstrual Blood Loss (MBL) [ Time Frame: at baseline and at 12 months following treatment ]

    Menstrual Blood Loss (MBL) scored dichotomously as follows:

    0 = Failure. Failure occurs if the change from baseline in MBL measurement is < 50 % as measured with alkaline hematin test (AHT) method.

    1 = Success. Success occurs if the change from baseline in MBL measurement is >= 50 %, or if the MBL is < 80 ml as measured with the AHT method.

Secondary Outcome Measures :
  1. Return to Activity [ Time Frame: 72 hours ]

    Length for Return to Activity after HIFU treatment measured dichotomously:

    0 = Failure. If subject takes longer than 72 hours to return to work or normal activity.

    1 = Success. If subject returns to work or normal activity within 72 hours inclusive.

  2. Symptom Severity Score (SSS) [ Time Frame: at baseline and at 12 months following treatment ]

    Symptom Severity Score (SSS) of Uterine Fibroid Symptom and Quality of Life questionnaire (UFS-QoL), assessed dichotomously at 12 months:

    0 = Failure. Reduction of less than 10 points on SSS.

    1 = Success. Reduction of at least 10 points on SSS.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Women, age between 18 and 50 years
  • Ethnicity has a match with the intended profile for the site
  • Weight < 140kg or 310lbs
  • Pre- or peri-menopausal as indicated by clinical evaluation or Follicle Stimulating Hormone (FSH) level < 40 IU/L
  • Willing and able to attend all study visits
  • Willing and able to complete Menstrual Blood Loss (MBL) assessment with Alkaline Hematin (AH) method
  • Willing and able to use reliable contraception methods
  • Uterine size < 24 weeks
  • Cervical cell assessment by Pap smear: Normal, Low Grade Squamous Intraepithelial Lesion (SIL), Low risk Human Papillomavirus (HPV) or Atypical Squamous Cells of Uncertain Significance (ASCUS) subtypes of cervical tissue
  • MR-HIFU device accessibility to fibroids such that at least 50% of the total fibroid volume can be treated.
  • Fibroids selected for treatment meeting the following criteria (further extrapolated in the protocol):

    1. Total planned ablation volume of all fibroids should not exceed 250 ml and
    2. No more than 5 fibroids should be planned for ablation and
    3. Dominant fibroid (diameter) is greater than or equal to 3 cm and
    4. Completely non-enhancing fibroids should not be treated as the identification of treated volume becomes ambiguous
  • Patient's self-assessment indicates that she has had episodes of heavy menstrual bleeding in the past 6 months.
  • Menstrual Blood Loss (MBL) ≥150 ml and ≤ 500 ml

Exclusion Criteria:

  • Other Pelvic Disease (Other mass, endometriosis, ovarian tumor, acute pelvic disease, significant adenomyosis)
  • Desire for future pregnancy
  • Significant systemic disease even if controlled
  • Positive pregnancy test
  • Hematocrit < 25%
  • Extensive scarring along anterior lower abdominal wall (>50% of area)
  • Surgical clips in the potential path of the HIFU beam
  • MRI contraindicated
  • MRI contrast agent contraindicated (including renal insufficiency)
  • Calcifications around or throughout uterine tissues that may affect treatment
  • Communication barrier
  • Highly perfused or brighter than myometrium in T2-weighted MRI (according to the T2 contrast obtained using the Philips MR-HIFU MR protocol) fibroids
  • Fibroids not quantifiable on MRI (e.g. multi-fibroid cases where volume measurements are not feasible)
  • Menses lasting > 7 days or intermenstrual bleeding (patient can be included if there is endometrial biopsy within 6 months to exclude malignancy)
  • Patient is currently on hormonal medication for fibroids or has a hormonal medication history as described below:

    1. 1-month Lupron dose or equivalent: less than 1 month prior to MBL measurement or
    2. 3-month Lupron dose or equivalent: less than 3 months prior to MBL measurement or
    3. Depo Provera or equivalent: less than 6 months prior to MBL measurement

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 ClinicalTrials.gov identifier (NCT number): NCT01504308

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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
United States, Oregon
Oregon Science and Health University
Portland, Oregon, United States, 97239
United States, Tennessee
Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235
St. Luke's Episcopal Hospital
Houston, Texas, United States, 77030
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Philips Healthcare
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Principal Investigator: John H Fischer II, MD St. Luke's Episcopal Hospital, Houston, Texas, United States
Principal Investigator: Robert K Zurawin, MD St. Luke's Episcopal Hospital, Houston, Texas, United States
Principal Investigator: Elizabeth David, MD Sunnybrook Health Sciences Center, Toronto, Ontario, Canada
Principal Investigator: Hyo Keun Lim, MD Samsung Medical Center, Seoul, Republic of Korea
Principal Investigator: Aytekin Oto, MD University of Chicago, Chicago, Illinois, United States
Principal Investigator: Amanda Yunker, D.O. Vanderbilt Medical Center
Principal Investigator: Peter Liu, M.D. University of Michigan
Principal Investigator: Rajiv Chopra, PhD University of Texas Southwestern Medical Center

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Responsible Party: Philips Healthcare
ClinicalTrials.gov Identifier: NCT01504308    
Other Study ID Numbers: 994045
G110008 ( Other Identifier: FDA )
First Posted: January 5, 2012    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Philips Healthcare:
uterine fibroids
uterine leiomyomas
magnetic resonance imaging
focused ultrasound
Additional relevant MeSH terms:
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Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases