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

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:

MedlinePlus related topics: Cancer Palliative Care

U.S. FDA Resources

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:	September 2013
Estimated Primary Completion Date:	September 2013 (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
MR-HIFU treatment date ≥ 4 weeks from participation in another clinical trial

Exclusion Criteria:

Planned treatment lesion is a primary bone tumor or due to lymphoma, multiple myeloma, or leukemia.
Communication barrier present
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

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

Contacts

Contact: Martin Deppe

martin.deppe@philips.com

Locations

India
Apollo Specialty Hospital	Not yet recruiting
Chennai, India, 600035
Principal Investigator: Bagyam Raghavan, MD
SRL Diagnostics - Jankharia Imaging	Not yet recruiting
Mumbai, India, 400013
Principal Investigator: Bhavin Jankharia, MD
Sub-Investigator: Karthik Ganesan, MD
Sub-Investigator: Devang Desai, MD
Indraprastha Apollo Hospital	Not yet recruiting
New Delhi, India, 110076
Principal Investigator: Harsh Rastogi, 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	Not yet 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:

Catane R, Beck A, Inbar Y, Rabin T, Shabshin N, Hengst S, Pfeffer RM, Hanannel A, Dogadkin O, Liberman B, Kopelman D. MR-guided focused ultrasound surgery (MRgFUS) for the palliation of pain in patients with bone metastases--preliminary clinical experience. Ann Oncol. 2007 Jan;18(1):163-7. Epub 2006 Oct 9.

Gianfelice D, Gupta C, Kucharczyk W, Bret P, Havill D, Clemons M. Palliative treatment of painful bone metastases with MR imaging--guided focused ultrasound. Radiology. 2008 Oct;249(1):355-63. Epub 2008 Aug 11.

Liberman B, Gianfelice D, Inbar Y, Beck A, Rabin T, Shabshin N, Chander G, Hengst S, Pfeffer R, Chechick A, Hanannel A, Dogadkin O, Catane R. Pain palliation in patients with bone metastases using MR-guided focused ultrasound surgery: a multicenter study. Ann Surg Oncol. 2009 Jan;16(1):140-6. Epub 2008 Nov 11.

Chow E, Hoskin P, Mitera G, Zeng L, Lutz S, Roos D, Hahn C, van der Linden Y, Hartsell W, Kumar E; International Bone Metastases Consensus Working Party. Update of the international consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):1730-7. Epub 2011 Apr 12.

Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singapore. 1994 Mar;23(2):129-38. Review.

Groenvold M, Petersen MA, Aaronson NK, Arraras JI, Blazeby JM, Bottomley A, Fayers PM, de Graeff A, Hammerlid E, Kaasa S, Sprangers MA, Bjorner JB; EORTC Quality of Life Group. The development of the EORTC QLQ-C15-PAL: a shortened questionnaire for cancer patients in palliative care. Eur J Cancer. 2006 Jan;42(1):55-64. Epub 2005 Sep 12.

Chow E, Hird A, Velikova G, Johnson C, Dewolf L, Bezjak A, Wu J, Shafiq J, Sezer O, Kardamakis D, Linden Y, Ma B, Castro M, Arnalot PF, Ahmedzai S, Clemons M, Hoskin P, Yee A, Brundage M, Bottomley A; EORTC Quality of Life Group; Collaboration for Cancer Outcomes Research and Evaluation. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for patients with bone metastases: the EORTC QLQ-BM22. Eur J Cancer. 2009 May;45(7):1146-52. Epub 2008 Dec 25.

Responsible Party:	Philips Healthcare
ClinicalTrials.gov Identifier:	NCT01586273 History of Changes
Other Study ID Numbers:	906273
Study First Received:	April 24, 2012
Last Updated:	December 3, 2012
Health Authority:	Netherlands: Medical Ethics Review Committee (METC) United Kingdom: Research Ethics Committee India: 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 May 22, 2013