Treatment of Uterine Fibroids With Magnetic Resonance Guided High Intensity Focused Ultrasound

The purpose of this study is to demonstrate the effectiveness of MR-HIFU for the treatment of uterine fibroids in Northwestern Ontario, which is a rural and remote setting.

Sex

Female

Minimum age

18 Years

Maximum age

50 Years

Inclusion Criteria:

* Women aged 18 to 50 years
* Weight \<140kg
* Pre or perimenopausal
* Uterine size \<24 weeks
* Cervical screen by Pap test: Normal, Low Grade Squamous Intraepithelial Lesion, or Atypical Squamous Cells of Undetermined Significance as per Cancer Care Ontario guidelines
* Transformed symptom severity score ≥40
* Willing to attend all study visits
* Willing to complete evaluation forms
* Willing and able to use reliable contraception;

MR-HIFU Criteria Trial Arm 1:

* Minimum of 50% of fibroid volume accessible for treatment
* Dominant fibroid ≤8 cm
* Uterine volume \<900 cc
* Total fibroid treatment volume \<250 cc
* No more than 5 fibroids planned for ablation
* Completely non-enhancing fibroids should not be treated

MR-HIFU Criteria Trial Arm 2:

* Minimum of 50% of fibroid volume accessible for treatment
* Dominant fibroid \>8 cm or uterine volume \>900 cc
* Total fibroid treatment volume \<250 cc
* No more than 5 fibroids planned for ablation
* Completely non-enhancing fibroids should not be treated

Exclusion Criteria:

* Other pelvic disease (endometriosis, ovarian tumor, acute pelvic disease, other mass)
* Significant systemic disease even if well controlled
* Positive pregnancy test
* Abnormal uterine bleeding (participant can be included if an endometrial biopsy confirms no hyperplasia or malignancy in the past 6 months)
* Extensive scarring along anterior abdominal wall (\>50% of area)
* Surgical clips or scar tissue in the path of the MR-HIFU beam
* MRI contraindicated according to standard operating procedure
* MRI contrast contraindicated (including renal insufficiency)
* Calcifications around or throughout uterine tissues
* Fibroids not quantifiable on MRI
* Highly perfused or brighter than myometrium in T2-weighted MRI fibroids (Type 3 fibroids).

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