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Pilot Study of MRI-Guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Philips Healthcare
ClinicalTrials.gov Identifier:
NCT00837161
First received: February 4, 2009
Last updated: November 30, 2012
Last verified: November 2012
History of Changes
  Purpose

Uterine fibroids (leiomyomas) are a common cause of heavy uterine bleeding and pain in reproductive aged women and are the most common cause of hysterectomy in the United States. Women are seeking new ways to treat symptomatic uterine fibroids that allow them to avoid surgery. This study is the first step in this quest. We will study the novel use of magnetic resonance imaging (MRI) in enhancing the safety of the FDA approved technique to treat fibroids called High Intensity Focused Ultrasound (HIFU). The term 'high intensity focused ultrasound' means using ultrasound to heat and to thermally destroy tissue, in this case, uterine fibroids. The MRI system will allow us to watch the ultrasound path during treatment and monitor the temperature increase in the fibroid tissue that comes during the procedure.

In this pilot study, women with symptomatic fibroids will undergo MRI guided HIFU and then have a hysterectomy. This will allow us to confirm studies done in animals which show that it is possible to destroy specific tissue without harming normal tissue surrounding the targeted area.

The purpose of this clinical study is to confirm the safety and treatment capabilities of the Philips MR guided HIFU system for ablation of uterine fibroids. This is a single arm pilot study of 10 women who will undergo hysterectomy after the HIFU procedure. This study design of hysterectomy after treatment has been requested by the FDA as part of IDE approval for this new device and mirrors what has been required for similar devices. Safety will be assessed by evaluating treatment accuracy, complications, and adverse events. Treatment capabilities will be assessed by evaluating the fibroid volume ablated and other factors related to the procedure feasibility and acceptance including procedure duration, time to return to normal activity, and pain scores at the time of the procedure.

Study population

The Philips MR-HIFU System is intended for ablation of uterine fibroid tissue in pre- or perimenopausal women with symptomatic uterine fibroids who desire a uterine-sparing procedure. Patients must have completed child bearing prior to enrolling in this study. Patients will be recruited by referral to gynecology and interventional radiology at the NIH Clinical Center. Candidates for enrollment will already have symptomatic uterine leiomyomas and be willing to undergo hysterectomy for treatment. It is estimated that of apparently eligible subjects, at least 30 women will have to be screened in person in order to identify 10 who will be eligible for this study. Other studies of fibroid treatments are currently ongoing at the NIH. Women who have been interested in, but have not been selected for enrollment in those studies and who appear to be eligible to this study will be contacted for potential enrollment.

Study design:

This study is a multi-center, single arm trial evaluating the safety and treatment capabilities of the Philips MR-guided HIFU system in the treatment of symptomatic uterine fibroid patients who are otherwise healthy women. All patients enrolled in the study will undergo hysterectomy within a window of 30 days following HIFU treatment. Patients who have symptomatic uterine fibroids, meet clinical indications for hysterectomy, are eligible according to the inclusion and exclusion criteria and provide informed consent will be enrolled in this study. This study design of treatment followed by hysterectomy has been requested by the FDA as part of IDE approval for this new device and mirrors what has been required for similar devices. It is anticipated that women will participate in the study for a 3 month period to include the screening, HIFU treatment, hysterectomy and post hysterectomy follow-up.

The methodology used for this HIFU device capitalizes on the thermal properties of volumetric ablation rather than point ablation used by other focused ultrasound systems. Thus it is anticipated that this device will have a shorter treatment time compared to other HIFU machines. This HIFU system, via real-time MR thermometry monitoring, has automated thermal feedback during the procedure which may enhance safety. This pilot study will not only assess the safety of this device but will enable us to delineate the treatment capabilities of this system for future use in patients who want uterine sparing non-surgical treatment for symptomatic fibroids.


Condition Intervention Phase
Uterine Fibroids
Uterine Leiomyomata
 Device: Philips MR guided HIFU system
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of MRI-Guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids

Resource links provided by NLM:

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Further study details as provided by Philips Healthcare:

Primary Outcome Measures:
  • Treatment-related Adverse Events (AE) Per Subject Resulting From HIFU Treatment of the Uterine Fibroids [ Time Frame: end of follow-up (date of hysterectomy, at latest day 30 after treatment) ] [ Designated as safety issue: Yes ]
    The number of treatment-related Adverse Events (AE) reported during the study, divided by the total number of treated subjects. This corresponds to the mean number of treatment-related Adverse Events per subject. Relatedness of an AE to the treatment was judged case-by-case by the investigator.


Secondary Outcome Measures:
  • HIFU Treatment Equals Location Per Hysterectomy [ Time Frame: Day 0, Hysterectomy ] [ Designated as safety issue: Yes ]
    Count the number of participants in which both of the following conditions are satisfied: the fibroid treated area as shown on MRI images during treatment is the same as displayed on fibroids from histology slices after hysterectomy, and no unintended lesions are visible in the uterus.

  • Length of Time to Return to Normal Activities [ Time Frame: end of follow-up (date of hysterectomy, at latest day 30 after treatment)] ] [ Designated as safety issue: No ]
    Length of time to return to normal activity measured in number of days from HIFU treatment. Assessed by patient interviews during follow-up.

  • Numerical Range Scale (NRS) of Pain Level [ Time Frame: Treatment Day: Baseline, Recovery, Discharge; Follow-up: 24 hours, 48 hours, 72 hours, 1 week, 2 weeks ] [ Designated as safety issue: No ]
    Pain Scores obtained by patient self-assessment on a 0-10 scale, with 0 corresponding to no pain and 10 corresponding to maximum pain.

  • Discomfort Level [ Time Frame: Treatment Day: Baseline, Recovery, Discharge; Follow-up: 24 hours, 48 hours, 72 hours, 1 week, 2 weeks ] [ Designated as safety issue: No ]
    Patient's self-assessed discomfort level on a 4-point scale, with: 0 = no pain; 1 = mild; 2 = moderate; 3 = severe.


Enrollment: 11
Study Start Date: January 2009
Study Completion Date: December 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Philips MR guided HIFU system
Patient receiving HIFU treatment
 Device: Philips MR guided HIFU system
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
Other Name: Philips Sonalleve MR-HIFU system

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

  • INCLUSION CRITERIA:

    1. Recommended for Total Abdominal Hysterectomy
    2. Age between 18 and 59
    3. Weight less than 140kg (or 310lbs)
    4. Pre or peri menopausal with FSH less than 40 mIU/ml
    5. Uterine size less than 24 weeks based on MRI and physical exam assessment
    6. Symptom severity score greater than or equal to 50 by Spies Uterine Fibroid Questionnaire.
    7. Cervical cytology no more severe than low grade SIL
    8. History of uterine leiomyoma causing symptoms of bleeding, pressure, or pain, as defined by the ACOG practice bulletin (ACOG Practice Bulletin 1994):
    9. Dominant intramural fibroid greater than or equal to 3 cm and less than or equal to 16 cm on imaging.

EXCLUSION CRITERIA:

  1. Other pelvic disease (mass indicated by history or MR imaging such as endometriosis, ovarian tumor, acute or chronic pelvic inflammatory disease)
  2. Desire for future pregnancy
  3. Significant systemic disease even if controlled
  4. Pregnant or Positive pregnancy test
  5. Hematocrit less than 25%
  6. Extensive scarring along anterior lower abdominal wall (greater than 50% of area) or scar tissue or surgical clips in the direct path of the HIFU beam
  7. MRI or MRI contrast agent contraindicated
  8. Unable to quantify or measure fibroids on MR exam including nonenhancing fibroids
  9. Fibroid or uterine calcifications
  10. Dominant fibroid is pedunculated or greater than 5 cm submucosal
  11. Communication barrier
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00837161

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
United States, Texas
St. Luke's Episcopal Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Philips Healthcare
  More Information

Additional Information:
NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Philips Healthcare
ClinicalTrials.gov Identifier: NCT00837161     History of Changes
Other Study ID Numbers: 994043
Study First Received: February 4, 2009
Results First Received: July 1, 2011
Last Updated: November 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Philips Healthcare:
High Intensity Focused Ultrasound Ablation
Uterine Fibroids
Leiomyomata
Non-Invasive Treatment of Uterine Fibroids
 MRI-Guided
Fibroids
Uterine Leiomyomata

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 16, 2013