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

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ClinicalTrials.gov Identifier: NCT02736435
Recruitment Status : Withdrawn (Lengthy delays and inadequate support to proceed.)
First Posted : April 13, 2016
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Thunder Bay Regional Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Uterine Leiomyoma Device: Magnetic Resonance Guided High Intensity Focused Ultrasound Drug: leuprolide acetate for depot suspension Phase 3

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  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Uterine Fibroids With Magnetic Resonance Guided High Intensity Focused Ultrasound
Actual Study Start Date : January 18, 2018
Actual Primary Completion Date : January 18, 2018
Actual Study Completion Date : January 18, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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 Name: 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 Name: MR-HIFU

Drug: leuprolide acetate for depot suspension
Treatment of uterine fibroids with leuprolide acetate prior to MR-HIFU
Other Name: Lupron Depot




Primary Outcome Measures :
  1. Change in uterine fibroid symptom severity scale [ Time Frame: 3, 6, and 12 months ]
    Assessing change from baseline value


Secondary Outcome Measures :
  1. Change in short form McGill pain questionnaire [ Time Frame: 24h, 72h, 6week, 3, 6, and 12 month ]
    Assessing change from baseline value

  2. Change in pictorial blood loss assessment chart [ Time Frame: 3, 6, and 12 months ]
    Assessing change from baseline value

  3. Change in uterine fibroid symptom and health-related quality of life questionnaire [ Time Frame: 12 months ]
    Assessing change from baseline value

  4. 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.

  5. MR Imaging to assess change in fibroid volume. [ Time Frame: 3, 6, and 12 months ]
    Assessing change from baseline value

  6. MR Imaging to assess change in perfusion. [ Time Frame: 3, 6, and 12 months ]
    Assessing change from baseline value

  7. Ultrasound imaging to assess change in fibroid volume. [ Time Frame: 3, 6, and 12 months ]
    Assessing change from baseline value

  8. Ultrasound imaging to assess change in fibroid perfusion. [ Time Frame: 3, 6, and 12 months ]
    Assessing change from baseline value


Other Outcome Measures:
  1. Return to activity within 72 hours of treatment [ Time Frame: 72 hours ]
  2. Change in hemoglobin level [ Time Frame: 3, 6, and 12 months ]
    Assessing change from baseline value



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736435


Locations
Canada, Ontario
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada, P7B 6V4
Sponsors and Collaborators
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:

Responsible Party: Thunder Bay Regional Research Institute
ClinicalTrials.gov Identifier: NCT02736435     History of Changes
Other Study ID Numbers: RP-317-07302014
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Thunder Bay Regional Research Institute:
Magnetic Resonance Guided High Intensity Focused Ultrasound
MR-HIFU
Fibroids
Leuprolide Acetate

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents