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

Primary Purpose

Leiomyoma, Fibroid

Status

Active

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Symphony MRI guided High Intensity Focused Ultrasound (HIFU)

About this trial

This is an interventional treatment trial for Leiomyoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

MR-HFU device accessibility to fibroids that at least 50% of fibroid volume can be treated
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
Transformed SSS score >= 40
Pre- or peri-menopausal, as indicated by clinical evaluation
Weight < 140 kg or 310 lbs
Willing and able to attend all study visits
Willing and able to use reliable contraception methods
Uterine size < 24 weeks
Cervical cell assessment by PAP: normal, LOW Grade SIL, Low risk HPV or ASCUS subtypes of cervical tissue
Waist circumference <110cm or 43 inches

Exclusion Criteria:

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

Sites / Locations

Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MR Guided High Intensity Focused Ultrasound

Arm Description

Outcomes

Primary Outcome Measures

The ability to ablate fibroid tissue measured by temperature elevation

Measured by MRI thermometry

The ability to ablate fibroid tissue indicated by Non-Perfused Volume (NPV)

Measure by contrast enhanced imaging

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.

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.

Secondary Outcome Measures

Treatment efficacy to reduce fibroid size

Reduction of fibroid volume in milliliters

Treatment efficacy to reduce fibroid size by NPV

Measured by non-perfused volume in milliliters

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.

Full Information

NCT ID

NCT03323905

First Posted

September 22, 2017

Last Updated

August 24, 2022

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Sunnybrook Research Institute, Arrayus Technologies Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03323905

Brief Title

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

Acronym

HIFUSB

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 16, 2017 (Actual)

Primary Completion Date

August 1, 2023 (Anticipated)

Study Completion Date

August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Sunnybrook Research Institute, Arrayus Technologies Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leiomyoma, Fibroid

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Pilot single arm feasibility trial.

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MR Guided High Intensity Focused Ultrasound

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Symphony MRI guided High Intensity Focused Ultrasound (HIFU)

Intervention Description

The use of the MRI-HIFU for the ablation of leiomyomas

Primary Outcome Measure Information:

Title

The ability to ablate fibroid tissue measured by temperature elevation

Description

Measured by MRI thermometry

Time Frame

1 year

Title

The ability to ablate fibroid tissue indicated by Non-Perfused Volume (NPV)

Description

Measure by contrast enhanced imaging

Time Frame

1 year

Title

Safety of the system measured by collection of adverse events related to potential damage to tissue outside the treatment zone

Description

Safety will be measured by collection of adverse events related to potential damage to tissue outside the treatment zone.

Time Frame

1 year

Title

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

Description

Safety will be measured by collection of adverse events related to potential damage to skin over the treatment volume.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Treatment efficacy to reduce fibroid size

Description

Reduction of fibroid volume in milliliters

Time Frame

1 year

Title

Treatment efficacy to reduce fibroid size by NPV

Description

Measured by non-perfused volume in milliliters

Time Frame

1 year

Title

Treatment efficacy to reduce symptom severity by Symptom Severity Scores (SSS)

Description

Change in symptoms to be quantified by Symptom Severity Scores (SSS) derived from Uterine Fibroid Symptom and Quality of Life questionnaire.

Time Frame

1 year

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: MR-HFU device accessibility to fibroids that at least 50% of fibroid volume can be treated Fibroids selected for treatment meet the following criteria Total planned ablation volume of all fibroids should not exceed 500 ml AND Completely non-enhancing fibroids should not be treated Transformed SSS score >= 40 Pre- or peri-menopausal, as indicated by clinical evaluation Weight < 140 kg or 310 lbs Willing and able to attend all study visits Willing and able to use reliable contraception methods Uterine size < 24 weeks Cervical cell assessment by PAP: normal, LOW Grade SIL, Low risk HPV or ASCUS subtypes of cervical tissue Waist circumference <110cm or 43 inches Exclusion Criteria: Other Pelvic Disease (Other mass, endometriosis, ovarian tumor, acute pelvic disease, significant adenomyosis, prolonged bleeding requiring further evaluation as determined by patient's gynecologist) Positive pregnancy test Extensive scarring along anterior lower - abdominal wall (>50% of area) Surgical clips in the potential path of the HIFU beam Tattoos in the potential path of the HIFU beam MRI contraindicated MRI contrast agent contraindicated (including renal insufficiency) Calcification around or throughout uterine tissue that may affect treatment Communication barrier Fibroids not quantifiable on MRI (e.g., multi-fibroid cases where volume measurements are not feasible) Pedunculated fibroids Bowel loops int he ultrasound beam path Patients with inability to tolerate prolonged prone position for up to 3 hours Patient with unstable medical conditions Patients with coagulopathy or under current anti-coagulation therapy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Elizabeth

Organizational Affiliation

Sunnybrook Reserach Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sunnybrook Health Sciences Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N3M5

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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