NCT02736435

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Thunder Bay Regional Health Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Uterine fibroids are benign smooth muscle tumours of the muscular wall of the uterus that affect 40 per cent of women. While the majority of fibroids are asymptomatic, fibroids may cause menorrhagia, bulk symptoms (i.e. ureteric obstruction, urinary frequency and urgency, bowel dysfunction), pain and in certain instances infertility. Magnetic resonance image-guided high-intensity focused ultrasound (MR-HIFU) treatment of fibroids is an established method for symptom alleviation with over 3000 women receiving treatment worldwide. MR-HIFU is a non-invasive, non-surgical procedure that uses ultrasound energy to thermally ablate the fibroid leading to a reduction in bleeding and in the size of uterine fibroids over time. MR-HIFU it is not currently being used for the treatment of symptomatic fibroids in Canada. The Thunder Bay Regional Research Institute has one of the first clinically available MR-HIFU equipment in Canada. In order to bring this technology into clinical practice, a knowledge translation study is needed to demonstrate that MR-HIFU can treat symptomatic uterine fibroids as successfully in Northwestern Ontario compared to urban centres where all of the clinical trials have been conducted. The ability to screen and follow up women treated with MR-HIFU with ultrasound rather than MRI would allow participants to receive follow up in regional centres in Northwestern Ontario and it would be more cost effective from a health system perspective. In addition, more research is needed to broaden the scope of treatment to include fibroids greater than 8 cm such that more women could benefit from this non-surgical fibroid management option.

Conditions

• Uterine Leiomyoma

Interventions

Type	Name	Description
DEVICE	Magnetic Resonance Guided High Intensity Focused Ultrasound	Direct treatment of uterine fibroids with MR-HIFU
DRUG	leuprolide acetate for depot suspension	Treatment of uterine fibroids with leuprolide acetate prior to MR-HIFU

Timeline

• Start date: 2018-01-18
• Primary completion: 2018-01-18
• Completion: 2018-01-18
• First posted: 2016-04-13
• Last updated: 2018-02-06

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study