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Bone MetastasisPhase 1/2NCT01309048

Magnetic Resonance-Guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases

A Phase 1/2 study testing Philips MR-guided HIFU system in people with Bone Metastasis, run by Philips Healthcare at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bone Metastasis
What is being tested?
Philips MR-guided HIFU system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteCanada
Study dates
Jan 2011to Jun 2012
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

Official title: Magnetic Resonance-Guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases - A Pilot Study

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.

Read the detailed description

Bone metastases are common among patients with advanced cancer and have been reported in up to 85% of cancer patients at autopsy. Complications of bone metastases include pain, functional limitation, decreased quality of life, pathological fracture, spinal cord compression and cauda equina syndrome.

External beam radiotherapy is the current standard treatment for patients with painful uncomplicated bone metastases. Unfortunately up to 30 % of patients treated with radiotherapy do not respond to therapy, and 30% of responders have their pain recur at some point after treatment. Radiotherapy re-treatment is also limited by cumulative doses delivered to sensitive structures. Ablative techniques such as cryotherapy and percutaneous radiofrequency ablation are not similarly limited by cumulative effects, however, they are invasive procedures that place patients at risk of complications.

MR-guided high intensity focused ultrasound (MR-HIFU) is a non-invasive, outpatient modality being investigated for the treatment of cancer. In MR-HIFU, a specially designed transducer is used to focus a beam of ultrasound energy into a small volume at a specific target site in the body. The focused beam produces therapeutic hyperthermia in the target field but only harmlessly warms the immediately surrounding tissue. Magnetic resonance (MR) imaging is used both to focus the ultrasound beam on the target field in the bone (the metastatic lesion and adjacent periosteum containing the nerves and vasculature for the tumor) and to perform real-time thermal mapping at and around the target. The mechanism of action of pain response is thought to be thermal periosteal denervation and / or thermal ablation of the tumor mass that diminishes pressure on the surrounding tissue.

Conditions
Bone Metastasis
Being tested
Philips MR-guided HIFU system
Keywords
bone metastasis, Patients with bone metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Philips MR-guided HIFU systemDevice

    Also called HIFU, Ablation, High Intensity Focused Ultrasound

    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.

Study groups in NCT01309048
Study groupRoleWhat they receive
Patients with painful bone metastasisExperimentalPatients with bone metastasis causing pain
Receives: Device: Philips MR-guided HIFU system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 90 Days

  2. Reduction of Pain Medication

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

    Measured: 90 Days

  3. 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.

    Measured: 90 Days

Secondary outcomes (2)

  1. Changes in bone density

    Measure changes in bone density between X-ray and CT images taken prior to and following treatment.

    Measured: 90 Days

  2. Quality of Life

    Measure patient quality of life using both the EORTC QLQ-BM22 and FACT-BP scales

    Measured: 90 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionJun 2012
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01309048
Sponsor's protocol ID
02082011
Status last verified
Aug 2012
First submitted
2 Mar 2011
Last updated
29 Aug 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 12242115

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Philips MR-guided HIFU system in people with Bone Metastasis, run by Philips Healthcare at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction of Pain Score (time frame: 90 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01309048, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2012.

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