NCT01309048

Brief Summary

This study is to confirm the safety and technical of MRI guided High Intensity Focused Ultrasound (HIFU) for Palliation for Pain of Skeletal Metastases. MRI guided high intensity focused ultrasound uses ultrasound to heat and thermally ablate tissue. The MRI system identifies the ultrasound path and monitors heat rise in the tissue. The goal of the study is to show treatment safety and effectiveness. MR-guided HIFU will be performed in patients who pass inclusion/exclusion criteria.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

August 29, 2012

Status Verified

August 1, 2012

Enrollment Period

1.4 years

First QC Date

March 2, 2011

Last Update Submit

August 28, 2012

Conditions

Bone Metastasis

Keywords

bone metastasisPatients with bone metastasis

Outcome Measures

Primary Outcomes (3)

  • Reduction of Pain Score

    Determine the efficacy of MR-Guided HIFU in reducing pain scores related to the site treated as measured on the Brief Pain Inventory (BPI).

    90 Days

  • Reduction of Pain Medication

    Determine the efficacy of MR-Guided HIFU in reducing pain medication usage

    90 Days

  • Complications and Adverse Events

    Document complications and adverse events as well as the number of unintended lesions that occur as a result of treatment with MR-Guided HIFU.

    90 Days

Secondary Outcomes (2)

  • Changes in bone density

    90 Days

  • Quality of Life

    90 Days

Study Arms (1)

Patients with painful bone metastasis

EXPERIMENTAL

Patients with bone metastasis causing pain

Device: Philips MR-guided HIFU system

Interventions

Philips MR-guided HIFU systemDEVICE

HIFU is the use of focused ultrasound energy to penetrate through soft tissue and causes localized high temperatures (55°C to 70°C) for a few seconds within the target producing well defined regions of protein and nerve denaturation, irreversible cell damage, and coagulative necrosis.

Also known as: HIFU, Ablation, High Intensity Focused Ultrasound
Patients with painful bone metastasis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Able to give informed consent
  • Weight \<140kg
  • Radiologic evidence of bone metastases from any solid tumor
  • Able to characterize pain specifically at the site of interest (target lesion)
  • Pain score related to target lesion of ≥4 on a 0-10 point scale irrespective of medications
  • Target lesion accessible for MR-HIFU procedure
  • Target lesion maximum dimension ≤8cm
  • Target lesion is uncomplicated (i.e.: no fracture / spinal cord compression / cauda equina syndrome / soft tissue component)
  • Target lesion visible by non-contrast MRI
  • Interface between bone and skin lies ≥1cm from surface
  • Able to communicate sensation during MR-HIFU treatment
  • MR-HIFU treatment date ≥2 weeks from most recent treatment of primary tumor or any chemotherapy.

You may not qualify if:

  • Prior radiotherapy / surgery / ablative therapy / other local therapy to target lesion.
  • Unable to characterize pain specifically at the site of interest (target lesion)
  • Pregnant / Nursing woman
  • Target lesion is complicated (i.e.: presence of one of fracture / spinal cord compression / cauda equina syndrome / soft tissue component).
  • Target lesion \<1cm from nerve bundles / bladder / bowel
  • Target lesion in contact with hollow viscera
  • Target lesion located in skull, spine (excluding sacrum which is allowed) or sternum
  • Scar along proposed HIFU beam path
  • Orthopaedic implant along proposed HIFU beam path or at site of target lesion.
  • Serious cardiovascular, neurological, renal or hematological chronic disease
  • Active infection
  • Unable to tolerate required stationary position during treatment
  • Allergy to MRI contrast agent or sedation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

  • Chow E, Wu JS, Hoskin P, Coia LR, Bentzen SM, Blitzer PH. International consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases. Radiother Oncol. 2002 Sep;64(3):275-80. doi: 10.1016/s0167-8140(02)00170-6.

    PMID: 12242115BACKGROUND

Study Officials

  • Greg Czarnota, M.D.

    Radiation Oncology, Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2011

First Posted

March 4, 2011

Study Start

January 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

August 29, 2012

Record last verified: 2012-08

Locations

CA(1)