Multicenter Study of Magnetic Resonance-guided High Intensity Focused Ultrasound for Pain Palliation of Bone Metastases

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Philips Healthcare
Sponsor:
Information provided by (Responsible Party):
Philips Healthcare
ClinicalTrials.gov Identifier:
NCT01586273
First received: April 24, 2012
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to evaluate the effectiveness of the Philips Sonalleve Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) device for treating painful bone metastases.


Condition Intervention
Bone Metastasis
Device: MR-HIFU treatment for pain palliation of bone metastases

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Magnetic Resonance-guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases - a Multicenter Study

Resource links provided by NLM:


Further study details as provided by Philips Healthcare:

Primary Outcome Measures:
  • Pain response to therapy [ Time Frame: 30 days after treatment ] [ Designated as safety issue: No ]

    Pain is measured using the Brief Pain Inventory (BPI) questionnaire. Patients are categorized into:

    • Complete response (CR): Pain score 0 without analgesic increase
    • Partial response (PR): Pain reduction of 2 or more without analgesic increase; or analgesic reduction of 25% without pain increase
    • Pain Progression (PP): Pain increase of 2 or more with stable analgesic use; or increase of 25% or more in analgesic use, with pain score stable or 1 point above baseline
    • No response corresponds to all other cases

    Patients with PR or CR at 30 days are considered responders to therapy.



Secondary Outcome Measures:
  • Total number of Adverse Events [ Time Frame: within the first 90 days within treatment ] [ Designated as safety issue: Yes ]
    Total number of complications and adverse events, including the number of unintended lesions that occur as a result of treatment with MR-HIFU.

  • Quality of Life (as measured by questionnaire) [ Time Frame: at day 0 before treatment, and at 7, 14, 30, 60 and 90 days after treatment ] [ Designated as safety issue: No ]
    Quality of Life will be measured at the given time points using a dedicated questionnaire for patients in palliative care: the European Organisation on Research and Treatment of Cancer (EORTC) C15-PAL questionnaire.

  • Subgroup analysis: pain response in radiation naïve patients [ Time Frame: 30 days after treatment ] [ Designated as safety issue: No ]
    Assessment of positive response on pain (as determined by the Primary Outcome Measure) will be documented separately for radiation naïve patients and radiation failure patients, and a comparison between the two sub-groups will be performed.

  • Temporal evolution of pain response during the first 30 days after treatment [ Time Frame: during the first 30 days after treatment ] [ Designated as safety issue: No ]
    Patients are given a diary to complete during the first 30 days after treatment, which documents their daily pain level on a 0-10 scale and their pain medication usage.


Estimated Enrollment: 64
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MR-HIFU treatment
Subjects undergo a MR-HIFU treatment for pain palliation of bone metastases on their most painful metastasis.
Device: MR-HIFU treatment for pain palliation of bone metastases
A treatment session with the Philips Sonalleve MR-HIFU device for bone pain palliation with high-intensity focused ultrasound.
Other Name: Philips Sonalleve MR-HIFU Bone Pain Palliative Therapy

Detailed Description:

Magnetic Resonance Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) is a non-invasive outpatient modality. In MR-HIFU, a specially designed ultrasound 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 is intended to produce therapeutic hyperthermia in the target field while only harmlessly warming the immediately surrounding tissue. Magnetic Resonance Imaging is used during the ultrasound treatment, both to focus the ultrasound beam on the target field and to perform real-time thermal mapping at and around the target.

The Philips Sonalleve MR-HIFU system is expected to be efficacious in reducing pain scores in patients with painful bone metastases and in reducing their pain medication usage.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women with age ≥ 18 years
  • Patient capable of giving informed consent and able to attend study visits
  • Weight < 140kg
  • Radiologic evidence of bone metastases from any solid tumor
  • Diagnosis of dominant painful bone metastasis (Numerical Representative Scale (NRS) pain score ≥4), either refractory to standard of care (including radiotherapy and optimal pain medication) or standard of care is contra-indicated or refused by patient.
  • Patient has been on stable pain medication for at least 1 week prior to HIFU treatment date
  • Pain is localized to the targeted area, or is likely to be referred pain arising from the targeted area
  • Patient has 1-3 painful lesions, and only the most painful lesion will be treated
  • Intended Target Volume accessible for MR-HIFU procedure
  • Target lesion maximum dimension ≤ 8cm
  • Intended target volume visible by non-contrast MRI
  • Distance between target and skin ≥ 1cm
  • Patient is able to communicate sensation during MR-HIFU treatment
  • MR-HIFU treatment date ≥ 4 weeks from last local treatment of the target lesion

Exclusion Criteria:

  • Planned treatment lesion is a primary bone tumor or due to lymphoma, multiple myeloma, or leukemia.
  • Communication barrier present
  • Patient enrolled in another clinical study related to bone metastases treatment or pain relief treatment
  • Unable to tolerate required stationary position during treatment
  • Need for surgical stabilization in case of (impending) fracture (lytic lesion in weight-bearing bone larger than 50% of bone diameter)
  • Pregnant woman
  • Pain related to target lesion is predominantly due to fracture or impending fracture
  • Pain related to target lesion is due to involvement of a neighboring major nerve by the metastatic tumor (cord or nerve compression)
  • Target < 3cm from bladder / bowel / nerve along the beam path and < 1cm in the plane orthogonal to the beam
  • Target in contact with hollow viscera
  • Target located in skull, joints, ribs (when HIFU beam overlapping with lung), spine (excluding sacrum which is allowed) or sternum
  • Scar along proposed HIFU beam path
  • Internal or external fixation device along the proposed HIFU beam path or at the target
  • MRI contraindicated (e.g. paramagnetic implants, pacemaker, claustrophobia)
  • MRI contrast agent contraindicated (e.g. previous anaphylaxis or Glomerular Filtration Rate (GFR) < 30 ml/min/1.73m2)
  • Sedation contraindicated
  • Previous surgery or minimally invasive treatment at targeted site
  • Clinically relevant medical history or abnormal physical findings that could interfere with the safety of the participant as judged by the treating physician or investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01586273

Contacts
Contact: Anne Niemi anne.niemi@philips.com

Locations
India
Apollo Specialty Hospital Withdrawn
Chennai, India, 600035
SRL Diagnostics - Jankharia Imaging Withdrawn
Mumbai, India, 400013
Indraprastha Apollo Hospital Withdrawn
New Delhi, India, 110076
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Principal Investigator: Young-sun Kim, MD         
Netherlands
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3508
Contact: Merel Huisman, MD       m.huisman-7@umcutrecht.nl   
Principal Investigator: Maurice A van den Bosch, MD, PhD         
Sub-Investigator: Merel Huisman, MD         
United Kingdom
Royal Marsden Hospital / Institute of Cancer Research Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Principal Investigator: Nandita de Souza, MD         
Sub-Investigator: Gail ter Haar, PhD         
Sponsors and Collaborators
Philips Healthcare
Investigators
Principal Investigator: Maurice A van den Bosch, MD, PhD UMC Utrecht
  More Information

Publications:

Responsible Party: Philips Healthcare
ClinicalTrials.gov Identifier: NCT01586273     History of Changes
Other Study ID Numbers: 906273
Study First Received: April 24, 2012
Last Updated: May 8, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
United Kingdom: Research Ethics Committee
India: Institutional Review Board
Korea: Food and Drug Administration
Korea: Institutional Review Board

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on July 31, 2014