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

NCT03323905 | Completed

• 1 other identifier: HIFUSB
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Leiomyoma; Fibroid

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Treatment efficacy to reduce fibroid size

  1 year

• Treatment efficacy to reduce fibroid size by NPV

  1 year

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

  1 year

Study Arms (1)

MR Guided High Intensity Focused Ultrasound

EXPERIMENTAL

Device: Symphony MRI guided High Intensity Focused Ultrasound (HIFU)

Interventions

Symphony MRI guided High Intensity Focused Ultrasound (HIFU) DEVICE

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

MR Guided High Intensity Focused Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Sunnybrook Research Institute: collaborator
• Arrayus Technologies Inc.: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• David Elizabeth

  Sunnybrook Reserach Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Affiliate scientist, Interventional Radiologist and Assistant Professor

Model Details: Pilot single arm feasibility trial.

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: October 27, 2017
• Study Start: November 16, 2017
• Primary Completion: December 1, 2023
• Study Completion: March 3, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

CA (1)