Clinical Trial: Therapeutic MRI Guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Therapeutic MRI Guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids

Brief Summary: This study is to collect supplementary safety and technical effectiveness data of Philips MRI guided High Intensity Focused Ultrasound (HIFU) in ablating uterine tissue associated with symptomatic fibroids in a 3T MRI scanner. 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 collect supplementary 3T treatment safety and technical effectiveness data in a 1 month follow-up study. MRguided 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.

Detailed Summary:

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 tem
Sponsor: Philips Healthcare

Current Primary Outcome:

  • Safety of HIFU for treatment of the uterine fibroids as determined by adverse event reporting. [ Time Frame: Day of treatment, 24, 48, 72 hrs, 1 and 2 wks and 30 days after treatment ]
    Safety of HIFU for treatment of the uterine fibroids as determined by adverse event reporting.
  • Technical efficacy of HIFU for treatment of uterine fibroids as assessed by a change in the Symptom Severity Score [ Time Frame: Day of treatment, 30 days after treatment ]
    Technical efficacy of HIFU for treatment of uterine fibroids as assessed by a change in the Symptom Severity Score


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Quality of Life Scores [ Time Frame: 0, 30 days ]
    Change in Quality of Life Scores
  • Pain score [ Time Frame: 0, 24, 48, 72 hours and 1 and 2 weeks, and 30 days ]
    Pain scores before, during and after treatment: This endpoints will be recorded using a 10-point visual analog scale for pain 4-point scale for discomfort.
  • Timeframe before returning to daily activities [ Time Frame: 0, 24, 48, 72 hours and 1 and 2 weeks, and 30 days ]
    Timeframe before returning to daily activities


Original Secondary Outcome: Same as current

Information By: Philips Healthcare

Dates:
Date Received: June 8, 2010
Date Started: June 2010
Date Completion:
Last Updated: December 3, 2012
Last Verified: December 2012