MR Guided Focused Ultrasound Surgery in the Treatment of Pain From Bone Tumors w/ the ExAblate 2000 Strappable System

NCT03547557 | Completed

• 1 other identifier: BM005
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

A Feasibility Study To Evaluate the Safety and initial Effectiveness of MR guided Focused Ultrasound Surgery in the Treatment of pain resulting from Metastatic Bone Tumors with the ExAblate 2000 strappable system.

Conditions

Bone Metastases

Keywords

Bone Tumors

Outcome Measures

Primary Outcomes (2)

• Number of participants with treatment-related adverse events

  adverse event incidence and severity

  Within 3 months of treatment

• Change in pain Numerical Rating Scale (NRS) from pre-treatment to post treatment

  NRS scale 0-10

  3 months post treatment

Study Arms (1)

ExAblate MRgFUS

EXPERIMENTAL

Device: Exablate 2000 strappable system

Interventions

Exablate 2000 strappable system DEVICE

ExAblate MRgFUS

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 age 18 and older
• Patients who are able and willing to give written consent and are able to attend all study visits
• Patients with histologically or cytologically confirmed malignant disease with a bone lesion that appears to be metastatic disease by clinical and or imaging techniques
• Patients with persistent pain from at least one site of bone metastases and are able to distinguish the pain from other painful sites oPatient with localized VAS pain score ≥ 4, at the target tumor oIn case of patients with more than one painful site, VAS pain score at the target site should exceed VAS pain score at any other site by at least two units.
• Targeted tumor(s) are ExAblate device accessible and are located in ribs, extremities (excluding joints), pelvis, shoulders and in the posterior aspects of the following spinal vertebra: Lumbar vertebra (L3 - L5), Sacral vertebra (S1 - S5)
• Targeted tumor(s) size is smaller than 8 cm in diameter on bone surface
• Patient whose lesion is on bone and is ≥ 10-mm from the skin.
• Tumor(s) clearly visible by non-contrast MRI
• Able to communicate sensations during the MRgFUS ExAblate treatment
• KPS ≥60 (See "Definitions" below)
• At least 2 weeks since chemotherapy
• At least 1 month since radiation therapy

You may not qualify if:

• Diffuse skeletal tumoral spread as evaluated by imaging.
• Patients who need pre-treatment surgical stabilization of the affected bony structure.
• Targeted tumor is in impending fracture
• Patients with unstable cardiac status including:
• Unstable angina pectoris on medication oPatients with documented myocardial infarction within six months of protocol entry oCongestive heart failure requiring medication (other than diuretic) oPatients on anti-arrhythmic drugs
• Severe hypertension (diastolic BP \> 100 on medication)
• Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations; weight \>110 kg, etc.
• Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist)
• Extensive scarring in an area in the path of energy planned passage to the treatment area
• Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
• Patients on anti-coagulation therapy or those with an underlying bleeding disorder
• Severely abnormal coagulation (INR\>1.5)the upper limit
• Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hrs.)
• Patients with life expectancy \< 6-Months
• Patients with surgical stabilization of tumor site with metallic hardware

Sponsors & Collaborators

• InSightec: lead

Study Sites (1)

Sheba Medical Center Oncology Department

Tel Litwinsky, 52621, Israel

Location

Related Links

• Sponsor's Web Page

MeSH Terms

Conditions

Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Prof. R. Catane

  Sheba Medical Center-Oncology Division

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 13, 2012
• First Posted: June 6, 2018
• Study Start: January 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: March 1, 2009
• Last Updated: June 6, 2018

Record last verified: 2018-06

Locations

IL (1)