Back to resultsSonalleve Fibroid Ablation Pivotal Clinical Trial for MR-HIFU of Uterine Fibroids (SOFIA)
Primary Purpose
Uterine Fibroids
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MR-HIFU treatment
Sham treatment
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Fibroids focused on measuring uterine fibroids, uterine leiomyomas, magnetic resonance imaging, focused ultrasound
Eligibility Criteria
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):
- Total planned ablation volume of all fibroids should not exceed 250 ml and
- No more than 5 fibroids should be planned for ablation and
- Dominant fibroid (diameter) is greater than or equal to 3 cm and
- 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-month Lupron dose or equivalent: less than 1 month prior to MBL measurement or
- 3-month Lupron dose or equivalent: less than 3 months prior to MBL measurement or
- Depo Provera or equivalent: less than 6 months prior to MBL measurement
Sites / Locations
- University of Chicago
- University of Michigan
- Montefiore Medical Center
- Oregon Science and Health University
- Vanderbilt Medical Center
- University of Texas Southwestern Medical Center
- St. Luke's Episcopal Hospital
- Sunnybrook Health Sciences Centre
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
MR-HIFU treatment
Sham Treatment
Arm Description
Patients receiving MR-HIFU treatment
Patients receiving sham treatment
Outcomes
Primary Outcome Measures
Alternative Interventional Treatment (AIT)
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).
Menstrual Blood Loss (MBL)
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
Return to Activity
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.
Symptom Severity Score (SSS)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01504308
Brief Title
Sonalleve Fibroid Ablation Pivotal Clinical Trial for MR-HIFU of Uterine Fibroids
Acronym
SOFIA
Official Title
Philips Pivotal Clinical Trial for MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
It was not possible to enroll patients into the study in a realistic timeframe.
Study Start Date
May 2012 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Healthcare
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids
Keywords
uterine fibroids, uterine leiomyomas, magnetic resonance imaging, focused ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MR-HIFU treatment
Arm Type
Experimental
Arm Description
Patients receiving MR-HIFU treatment
Arm Title
Sham Treatment
Arm Type
Sham Comparator
Arm Description
Patients receiving sham treatment
Intervention Type
Device
Intervention Name(s)
MR-HIFU treatment
Other Intervention Name(s)
Philips Sonalleve MR-HIFU Uterine Fibroid Therapy
Intervention Description
A treatment session with the Philips Sonalleve MR-HIFU device for thermal ablation of uterine fibroids with high-intensity focused ultrasound.
Intervention Type
Device
Intervention Name(s)
Sham treatment
Other Intervention Name(s)
pretend treatment with Philips Sonalleve MR-HIFU
Intervention Description
A pretend treatment session with the Philips Sonalleve MR-HIFU system in which no therapeutic ultrasound doses are delivered.
Primary Outcome Measure Information:
Title
Alternative Interventional Treatment (AIT)
Description
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).
Time Frame
12 months after HIFU treatment
Title
Menstrual Blood Loss (MBL)
Description
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.
Time Frame
at baseline and at 12 months following treatment
Secondary Outcome Measure Information:
Title
Return to Activity
Description
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.
Time Frame
72 hours
Title
Symptom Severity Score (SSS)
Description
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.
Time Frame
at baseline and at 12 months following treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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):
Total planned ablation volume of all fibroids should not exceed 250 ml and
No more than 5 fibroids should be planned for ablation and
Dominant fibroid (diameter) is greater than or equal to 3 cm and
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-month Lupron dose or equivalent: less than 1 month prior to MBL measurement or
3-month Lupron dose or equivalent: less than 3 months prior to MBL measurement or
Depo Provera or equivalent: less than 6 months prior to MBL measurement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John H Fischer II, MD
Organizational Affiliation
St. Luke's Episcopal Hospital, Houston, Texas, United States
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert K Zurawin, MD
Organizational Affiliation
St. Luke's Episcopal Hospital, Houston, Texas, United States
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elizabeth David, MD
Organizational Affiliation
Sunnybrook Health Sciences Center, Toronto, Ontario, Canada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hyo Keun Lim, MD
Organizational Affiliation
Samsung Medical Center, Seoul, Republic of Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aytekin Oto, MD
Organizational Affiliation
University of Chicago, Chicago, Illinois, United States
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amanda Yunker, D.O.
Organizational Affiliation
Vanderbilt Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Liu, M.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rajiv Chopra, PhD
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Oregon Science and Health University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Vanderbilt Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
St. Luke's Episcopal Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
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Sonalleve Fibroid Ablation Pivotal Clinical Trial for MR-HIFU of Uterine Fibroids
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