Therapeutic Magnetic Resonance Imaging (MRI)-Guided High Intensity Focused Ultrasound (HIFU) Ablation of Uterine Fibroids
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional

Summary: 
      This study is to confirm the safety and technical effectiveness of MRI guided High Intensity
      Focused Ultrasound (HIFU) in ablating uterine tissue associated with symptomatic leiomyomas.
      The importance of this therapy is that it offers a non-invasive, uterine sparing procedure
      for the treatment of uterine fibroids in pre- and peri- menopausal women.

      MRI guided high intensity focused ultrasound uses ultrasound to heat and thermally ablate
      fibroid tissue. The MRI system identifies the ultrasound path and monitors heat rise in the
      fibroid tissue. The goal of the study is to show treatment safety and technical
      effectiveness. MR-guided HIFU will be performed in patients who pass inclusion/exclusion
      criteria. Safety, quality of life, and imaging endpoints will be evaluated in all study
      patients.

      The goal of this study is to demonstrate that:

        1. The safety profile is acceptable (safety)

        2. Actual MR-HIFU ablated volumes (as measured with contrast enhanced MRI) match the
           intended volumes (technical effectiveness)

        3. When intended, volumes greater than 20% of the fibroid volume can be successfully
           ablated (technical effectiveness)

      The investigators' hypothesis is that greater than 70% of fibroids will have concordance
      between intended lesion volume and actual lesion volume while maintaining an acceptable
      safety profile.
    

Detailed description: 
      Fibroids occur in 20-50% of women over 30 years of age, and with increasing size produce
      pain, menorrhagia, pressure, bloating and urinary and bowel compression symptoms. Fibroids
      may also cause infertility. Uterine leiomyomas are benign tumors originating from smooth
      muscle cells of the uterus and occasionally the smooth muscle of uterine blood vessels.
      Fibroids are estrogen dependent tumors ranging in size and number and can be found within the
      myometrium(intramural), at the uterine periphery extending to the serosa (subserosal), or
      pushing into the uterine cavity (submucosal). 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 (GnRH analogues or progestin compounds) or treatments causing
      necrosis of the fibroid tissue such as ablation (freezing or heating) or embolization. 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.
      HIFU may offer an alternative to the above mentioned surgically invasive procedures.

      In MRI-guided High Intensity Focused Ultrasound (HIFU), the ultrasound generated by the
      transducer is focused into a small focal tissue volume at specific target locations. During
      treatment, the beam of focused ultrasound energy penetrates 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.
      The MRI system allows 3D planning, means of measuring the temperature increase generated by
      HIFU, and the capability to quantifying the energy/dose delivered to the treatment zone.

      This study is a multi-center, single arm, non-randomized trial evaluating the safety,
      technical effectiveness and volume treatment capabilities of the Philips MR-guided HIFU
      system in the treatment of symptomatic uterine fibroid patients. Patients who have
      symptomatic uterine fibroids, who are eligible according to the inclusion and exclusion
      criteria and provide informed consent will be enrolled in this study. It is anticipated that
      women will participate in the study for a 2month period to include the screening, HIFU
      treatment and post treatment follow-up.

      This clinical study is designed to confirm safety and demonstrate technical effectiveness of
      the Philips HIFU system for Uterine Fibroid treatment. Safety will be primarily assessed by
      evaluating minor complications and adverse events, and technical effectiveness will primarily
      be assessed with MRI measurements. Specific primary and secondary endpoints are detailed
      below.

      The study will use a combination of three primary endpoints: MR imaging of ablated volumes
      and minor complications/adverse events analysis to establish the safety and technical
      effectiveness of the Philips MR-HIFU system. These endpoints will determine the trial
      success.

      The treatment capabilities and technical effectiveness of the Philips MR-guided HIFU system
      will be assessed by (measurement type is noted in parentheses)

        1. Comparing the actual MR-measured ablated volumes to MR thermal dose predicted volumes

           Safety of the Philips MR-guided HIFU system will be demonstrated by

        2. Evaluating any minor complications or adverse events that result from the MR-guided HIFU
           treatment

        3. Verifying with MR imaging that no unintended lesions are formed as a result of the
           Treatment

           Our hypothesis is that greater than 70% of fibroids will have concordance between
           intended lesion volume and actual lesion volume while maintaining an acceptable safety
           profile.

           In addition, the following endpoints will be collected to supplement the primary
           outcomes:

        4. Pain and discomfort scores before, during and after treatment: These endpoints will be
           recorded using a 10-point visual analog scale for pain 4-point scale for discomfort.

        5. Return to Activity: This duration in days will be determined by the time after which the
           patients return to work (i.e. days after leaving the hospital) or to the usual
           activities for those not employed.

        6. Length of Hospital Stay (LOS): This duration in hours will be measured from the time the
           patient will arrive to the hospital until she will leave the hospital.

        7. Quality of Life questionnaires: the SF-36(http://www.sf36.org/tools/SF36.shtml) and
           UFS-QoL (which includes SSS)
    

Intervention name(s): Philips MRI-guided HIFU system
Intervention type(s): Device
Intervention description(s): 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 intervention name(s): Sonalleve
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Uterine Leiomyomas; Fibroids; HIFU; Ablation; High Intensity Focused Ultrasound