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

NCT01586273 | Terminated DMC

• 1 other identifier: 906273
• Study Type: interventional
• Target: 20
• Locations: 3 countries
• Sites: 3

Brief Summary

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.

Conditions

Bone Metastasis

Outcome Measures

Primary Outcomes (1)

• Pain response to therapy

  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.

  30 days after treatment

Secondary Outcomes (4)

• Total number of Adverse Events

  within the first 90 days within treatment

• Quality of Life (as measured by questionnaire)

  at day 0 before treatment, and at 7, 14, 30, 60 and 90 days after treatment

• Subgroup analysis: pain response in radiation naïve patients

  30 days after treatment

• Temporal evolution of pain response during the first 30 days after treatment

  during the first 30 days after treatment

Study Arms (1)

MR-HIFU treatment

EXPERIMENTAL

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

Interventions

MR-HIFU treatment for pain palliation of bone metastases DEVICE

A treatment session with the Philips Sonalleve MR-HIFU device for bone pain palliation with high-intensity focused ultrasound.

Also known as: Philips Sonalleve MR-HIFU Bone Pain Palliative Therapy

MR-HIFU treatment

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Philips Healthcare: lead

Study Sites (3)

University Medical Center Utrecht

Utrecht, 3508, Netherlands

Location

Samsung Medical Center

Seoul, South Korea

Location

Royal Marsden Hospital / Institute of Cancer Research

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Related Publications (7)

• 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):163-167. doi: 10.1093/annonc/mdl335. Epub 2006 Oct 9.

  PMID: 17030549 BACKGROUND

• 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. doi: 10.1148/radiol.2491071523. Epub 2008 Aug 11.

  PMID: 18695209 BACKGROUND

• 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. doi: 10.1245/s10434-008-0011-2. Epub 2008 Nov 11.

  PMID: 19002530 BACKGROUND

• 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. doi: 10.1016/j.ijrobp.2011.02.008. Epub 2011 Apr 12.

  PMID: 21489705 BACKGROUND

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

  PMID: 8080219 BACKGROUND

• 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. doi: 10.1016/j.ejca.2005.06.022. Epub 2005 Sep 12.

  PMID: 16162404 BACKGROUND

• Chow E, Hird A, Velikova G, Johnson C, Dewolf L, Bezjak A, Wu J, Shafiq J, Sezer O, Kardamakis D, van der 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. 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):1146-1152. doi: 10.1016/j.ejca.2008.11.013. Epub 2008 Dec 25.

  PMID: 19097882 BACKGROUND

Study Officials

• Maurice A van den Bosch, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2012
• First Posted: April 26, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: November 1, 2016
• Last Updated: April 4, 2017

Record last verified: 2017-04

Locations

GB (1); KR (1); NL (1)