Single Arm Study Using the Symphony -- MRI Guided Focused Ultrasound System for the Treatment of Leiomyomas (HIFUSB)

MRI-guided High Intensity Focused Ultrasound Ablation of Leiomyomas. Single Arm, Feasibility Study Using the Symphony - MRI Guided Focused Ultrasound System for the Treatment of Leiomyomas

Single arm, first-in human feasibility study using the Symphony - MRI guided focused ultrasound system for the treatment of leiomyomas. The study is expected to accrue over 12 months. This study will help determine the feasibility to ablate leiomyomas, as measured by MR thermometry and contrast enhanced imaging. In addition, the study will look at the efficacy and safety of the treatment, as measured by the reduction in fibroid size and reduction in symptom severity score and adverse events. This study will help develop future pivotal trials using the same device.

Study Overview

• Status: Completed
• Conditions: Leiomyoma; Fibroid
• Intervention / Treatment: Device: Symphony MRI guided High Intensity Focused Ultrasound (HIFU)

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N3M5
      • Sunnybrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. MR-HFU device accessibility to fibroids that at least 50% of fibroid volume can be treated

2. Fibroids selected for treatment meet the following criteria

   1. Total planned ablation volume of all fibroids should not exceed 500 ml AND
   2. Completely non-enhancing fibroids should not be treated
3. Transformed SSS score >= 40
4. Pre- or peri-menopausal, as indicated by clinical evaluation
5. Weight < 140 kg or 310 lbs
6. Willing and able to attend all study visits
7. Willing and able to use reliable contraception methods
8. Uterine size < 24 weeks
9. Cervical cell assessment by PAP: normal, LOW Grade SIL, Low risk HPV or ASCUS subtypes of cervical tissue
10. Waist circumference <110cm or 43 inches

Exclusion Criteria:

1. Other Pelvic Disease (Other mass, endometriosis, ovarian tumor, acute pelvic disease, significant adenomyosis, prolonged bleeding requiring further evaluation as determined by patient's gynecologist)
2. Positive pregnancy test
3. Extensive scarring along anterior lower - abdominal wall (>50% of area)
4. Surgical clips in the potential path of the HIFU beam
5. Tattoos in the potential path of the HIFU beam
6. MRI contraindicated
7. MRI contrast agent contraindicated (including renal insufficiency)
8. Calcification around or throughout uterine tissue that may affect treatment
9. Communication barrier
10. Fibroids not quantifiable on MRI (e.g., multi-fibroid cases where volume measurements are not feasible)
11. Pedunculated fibroids
12. Bowel loops int he ultrasound beam path
13. Patients with inability to tolerate prolonged prone position for up to 3 hours
14. Patient with unstable medical conditions
15. Patients with coagulopathy or under current anti-coagulation therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MR Guided High Intensity Focused Ultrasound	Device: Symphony MRI guided High Intensity Focused Ultrasound (HIFU); The use of the MRI-HIFU for the ablation of leiomyomas

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The ability to ablate fibroid tissue measured by temperature elevation	Measured by MRI thermometry	1 year
The ability to ablate fibroid tissue indicated by Non-Perfused Volume (NPV)	Measure by contrast enhanced imaging	1 year
Safety of the system measured by collection of adverse events related to potential damage to tissue outside the treatment zone	Safety will be measured by collection of adverse events related to potential damage to tissue outside the treatment zone.	1 year
Safety of the system based on damage to skin measured by collection of adverse events related to potential damage to skin over the treatment volume	Safety will be measured by collection of adverse events related to potential damage to skin over the treatment volume.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment efficacy to reduce fibroid size	Reduction of fibroid volume in milliliters	1 year
Treatment efficacy to reduce fibroid size by NPV	Measured by non-perfused volume in milliliters	1 year
Treatment efficacy to reduce symptom severity by Symptom Severity Scores (SSS)	Change in symptoms to be quantified by Symptom Severity Scores (SSS) derived from Uterine Fibroid Symptom and Quality of Life questionnaire.	1 year

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: Sunnybrook Research Institute; Arrayus Technologies Inc.
• Investigators: Principal Investigator: David Elizabeth, Sunnybrook Reserach Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2017
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): March 3, 2024

Study Registration Dates

• First Submitted: September 22, 2017
• First Submitted That Met QC Criteria: October 24, 2017
• First Posted (Actual): October 27, 2017

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: July 8, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: HIFUSB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No