China Clinical Trial for Therapeutic MR-HIFU Ablation of Uterine Fibroids

This study is to confirm the safety and effectiveness of Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-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.

MR-HIFU 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 effectiveness of the Philips Sonalleve MR-HIFU device for uterine fibroids marketing approval in the Chinese market. MR-HIFU will be performed in 100 patients who pass inclusion/exclusion criteria. Safety, quality of life, and imaging endpoints will be evaluated in all study patients at baseline and at 6 months post-treatment. All patients will be followed up for 12 months post-treatment for safety.

Inclusion criteria

• Women, age between 18 and 55 years
• Weight < 140 kg
• Pre- or peri-menopausal
• Uterine size < 24 weeks
• Cervical cell assessment by Pap smear/Thin-prep Cytologic Test (TCT): Normal, Low Grade Squamous Intraepithelial Lesion (SIL), Low risk Human Papillomavirus (HPV) or Atypical Squamous Cells of Uncertain Significance (ASCUS) subtypes of cervical tissue
• Fibroids selected for treatment meeting the following criteria:

• Total planned ablation volume of all fibroids should not exceed 250 ml, and
• No more than 5 fibroids should be planned for ablation, and
• Dominant fibroid (diameter) is greater than or equal to 3 cm, and
• Fibroids which are completely non-enhancing under Magnetic Resonance (MR) contrast agent should not be treated as the identification of treated volume becomes ambiguous
• Highly perfused or brighter than myometrium in T2-weighted MRI (according to the T2 contrast obtained using the Philips MR-HIFU protocol) fibroids should not be treated
• MR-HIFU device accessibility to fibroids such that at least 50% of the total fibroid volume can be treated
• Willing and able to attend all study visits

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 direct path of the HIFU beam
• MRI contraindicated
• MRI contrast agent contraindicated
• Fibroids not quantifiable on MRI (e.g. multi-fibroid cases where volume measurements are not feasible)
• Calcifications around or throughout uterine tissues
• Communication barrier
• Suspected malignancy