Clinical trial NCT01504308: Sonalleve Fibroid Ablation Pivotal Clinical Trial for MR-HIFU of Uterine Fibroids
Official title: Philips Pivotal Clinical Trial for MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Uterine Fibroids
Keywords: uterine fibroids
uterine leiomyomas
magnetic resonance imaging
focused ultrasound
Lead sponsor: Philips Healthcare
Sponsor class: INDUSTRY
First posted: 2012-01-05
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Alternative Interventional Treatment (AIT)
timeFrame: 12 months after HIFU treatment
measure: Menstrual Blood Loss (MBL)
timeFrame: at baseline and at 12 months following treatment
Secondary outcomes:
measure: Return to Activity
timeFrame: 72 hours
measure: Symptom Severity Score (SSS)
timeFrame: at baseline and at 12 months following treatment
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Portland
country: United States
facility: Oregon Science and Health University
state: Oregon
city: Nashville
country: United States
facility: Vanderbilt Medical Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: St. Luke's Episcopal Hospital
state: Texas
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: St. Luke's Episcopal Hospital, Houston, Texas, United States
name: John H Fischer II, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Luke's Episcopal Hospital, Houston, Texas, United States
name: Robert K Zurawin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Center, Toronto, Ontario, Canada
name: Elizabeth David, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center, Seoul, Republic of Korea
name: Hyo Keun Lim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago, Chicago, Illinois, United States
name: Aytekin Oto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt Medical Center
name: Amanda Yunker, D.O.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Peter Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Southwestern Medical Center
name: Rajiv Chopra, PhD
role: PRINCIPAL_INVESTIGATOR
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