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

February 2, 2018 updated by: Thunder Bay Regional Research Institute
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • Thunder Bay Regional Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fibroid dimension < 8 cm

Women with a maximum fibroid dimension less than 8 cm and a total uterine volume less than 900 cc.

Intervention: Treatment of fibroids with Magnetic Resonance Guided High Intensity Focused Ultrasound.
Device: Magnetic Resonance Guided High Intensity Focused Ultrasound
Direct treatment of uterine fibroids with MR-HIFU
Other Names:
  • MR-HIFU
Experimental: Fibroid dimension > 8 cm

Women with a maximum fibroid dimension greater than 8 cm or a total uterine volume greater than 900 cc.

Intervention A: Pre-treated with 11.25mg leuprolide acetate for depot suspension for 3 months to reduce size of fibroids.

Intervention B: Treatment with Magnetic Resonance Guided High Intensity Focused Ultrasound if fibroids decrease to treatable size of less than 8cm and uterine volume less than 900cc.
Device: Magnetic Resonance Guided High Intensity Focused Ultrasound
Direct treatment of uterine fibroids with MR-HIFU
Other Names:
  • MR-HIFU
Drug: leuprolide acetate for depot suspension
Treatment of uterine fibroids with leuprolide acetate prior to MR-HIFU
Other Names:
  • Lupron Depot

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in uterine fibroid symptom severity scale
Time Frame: 3, 6, and 12 months
Assessing change from baseline value
3, 6, and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in short form McGill pain questionnaire
Time Frame: 24h, 72h, 6week, 3, 6, and 12 month
Assessing change from baseline value
24h, 72h, 6week, 3, 6, and 12 month
Change in pictorial blood loss assessment chart
Time Frame: 3, 6, and 12 months
Assessing change from baseline value
3, 6, and 12 months
Change in uterine fibroid symptom and health-related quality of life questionnaire
Time Frame: 12 months
Assessing change from baseline value
12 months
Participant use of alternative therapies for treatment of fibroids
Time Frame: 6 weeks, 3, 6, and 12 months
Questionnaire to assess if participants are selecting to use alternative treatments for relief of symptoms of uterine fibroids.
6 weeks, 3, 6, and 12 months
MR Imaging to assess change in fibroid volume.
Time Frame: 3, 6, and 12 months
Assessing change from baseline value
3, 6, and 12 months
MR Imaging to assess change in perfusion.
Time Frame: 3, 6, and 12 months
Assessing change from baseline value
3, 6, and 12 months
Ultrasound imaging to assess change in fibroid volume.
Time Frame: 3, 6, and 12 months
Assessing change from baseline value
3, 6, and 12 months
Ultrasound imaging to assess change in fibroid perfusion.
Time Frame: 3, 6, and 12 months
Assessing change from baseline value
3, 6, and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Return to activity within 72 hours of treatment
Time Frame: 72 hours
72 hours
Change in hemoglobin level
Time Frame: 3, 6, and 12 months
Assessing change from baseline value
3, 6, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thunder Bay Regional Research Institute

Investigators

  • Principal Investigator: Naana A Jumah, MD DPhil FRCSC, Northern Ontario School of Medicine, Thunder Bay Regional Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2018

Primary Completion (Actual)

January 18, 2018

Study Completion (Actual)

January 18, 2018

Study Registration Dates

First Submitted

March 18, 2016

First Submitted That Met QC Criteria

April 12, 2016

First Posted (Estimate)

April 13, 2016

Study Record Updates

Last Update Posted (Actual)

February 6, 2018

Last Update Submitted That Met QC Criteria

February 2, 2018

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP-317-07302014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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