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).
Brief Title
Sonalleve Fibroid Ablation Pivotal Clinical Trial for MR-HIFU of 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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Uterine Fibroids
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):
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
* 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
Inclusion 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):
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
* 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
Gender
Female
Gender Based
false
Keywords
uterine fibroids
uterine leiomyomas
magnetic resonance imaging
focused ultrasound
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
50 Years
Minimum Age
18 Years
NCT Id
NCT01504308
Org Class
Industry
Org Full Name
Philips Healthcare
Org Study Id
994045
Overall Status
Terminated
Phases
Phase 2
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Philips Pivotal Clinical Trial for MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids
Primary Outcomes
Outcome 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).
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).
Outcome Measure
Alternative Interventional Treatment (AIT)
Outcome Time Frame
12 months after HIFU treatment
Outcome 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.
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.
Outcome Measure
Menstrual Blood Loss (MBL)
Outcome Time Frame
at baseline and at 12 months following treatment
Secondary Ids
Secondary Id
G110008
Secondary Outcomes
Outcome 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.
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.
Outcome Time Frame
72 hours
Outcome Measure
Return to Activity
Outcome 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.
0 = Failure. Reduction of less than 10 points on SSS.
1 = Success. Reduction of at least 10 points on SSS.
Outcome Time Frame
at baseline and at 12 months following treatment
Outcome Measure
Symptom Severity Score (SSS)
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
50
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Scott Chudnoff
Investigator Email
schudnof@montefiore.org
Investigator Phone
Categories Mesh Debug
Brain, Spine & Nerve Cancers --- NEOPLASMS, CONNECTIVE AND SOFT TISSUE
Cancer --- NEOPLASMS
MeSH Terms
LEIOMYOMA
MYOFIBROMA
NEOPLASMS, MUSCLE TISSUE
NEOPLASMS, CONNECTIVE AND SOFT TISSUE
NEOPLASMS BY HISTOLOGIC TYPE
NEOPLASMS
NEOPLASMS, CONNECTIVE TISSUE
CONNECTIVE TISSUE DISEASES
SKIN AND CONNECTIVE TISSUE DISEASES
PLACEBOS
PHARMACEUTICAL PREPARATIONS
THERAPEUTICS