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China Clinical Trial for Therapeutic MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids

18 Years
55 Years
Open (Enrolling)
Uterine Fibroids

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Trial Information

China Clinical Trial for Therapeutic MRI-guided High Intensity Focused Ultrasound 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

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:

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. Fibroids which are completely non-enhancing under Magnetic Resonance (MR)
contrast agent should not be treated as the identification of treated volume
becomes ambiguous

5. 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in fibroid volume

Outcome Description:

Proportion of patients with treated fibroid volume at 6 months after treatment reduced to 90% or less of treated fibroid volume at baseline (before MR-HIFU treatment)

Outcome Time Frame:

At baseline and at 6 months after treatment

Safety Issue:


Principal Investigator

Qinping Liao

Investigator Role:

Principal Investigator

Investigator Affiliation:

Peking University First Hospital


China: Food and Drug Administration

Study ID:




Start Date:

May 2012

Completion Date:

June 2014

Related Keywords:

  • Uterine Fibroids
  • Uterine Leiomyomas
  • Fibroids
  • HIFU
  • Ablation
  • High Intensity Focused Ultrasound
  • Leiomyoma
  • Myofibroma