Clinical trial NCT01586273: Multicenter Study of Magnetic Resonance-guided High Intensity Focused Ultrasound for Pain Palliation of Bone Metastases
Official title: Magnetic Resonance-guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases - a Multicenter Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bone Metastasis
Lead sponsor: Philips Healthcare
Sponsor class: INDUSTRY
First posted: 2012-04-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Pain response to therapy
timeFrame: 30 days after treatment
Secondary outcomes:
measure: Total number of Adverse Events
timeFrame: within the first 90 days within treatment
measure: Quality of Life (as measured by questionnaire)
timeFrame: at day 0 before treatment, and at 7, 14, 30, 60 and 90 days after treatment
measure: Subgroup analysis: pain response in radiation naïve patients
timeFrame: 30 days after treatment
measure: Temporal evolution of pain response during the first 30 days after treatment
timeFrame: during the first 30 days after treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital / Institute of Cancer Research
state: Surrey
Study officials:
affiliation: UMC Utrecht
name: Maurice A van den Bosch, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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