NCT01085565

Brief Summary

The goal of this prospective, non-randomized, single-arm, phase 2 study is to evaluate the safety and effectiveness of this treatment using this ExAblate conformal system in the treatment of pain resulting from metastatic bone tumors Up to Fifty (50) patients will be recruited in this feasibility study. The treated patients will be followed for 3-Months post their last treatment, patients with the standard contraindications to MRI examination, such as implanted metal devices (pacemakers, etc.), will be excluded.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 8, 2016

Status Verified

March 1, 2016

Enrollment Period

3 years

First QC Date

March 11, 2010

Last Update Submit

March 7, 2016

Conditions

Bone CancerBone MetastasesPain

Keywords

Bone cancerBone Metastasespain palliationmetastasisbreast cancerlung cancerprostate cancercancer related paintumors

Outcome Measures

Primary Outcomes (1)

  • Safety

    Evaluate incidence and severity of adverse events associated with ExAblate MRgFUS ExAblate Conformal system used in the palliation of pain due to metastatic bone tumors

    3 months post treatment

Secondary Outcomes (3)

  • Efficacy

    3 months post treatment

  • Effectiveness

    3 months post treatment

  • Effectiveness

    3 months post treatment

Study Arms (1)

Exablate treatment

EXPERIMENTAL
Device: ExAblate 2100

Interventions

ExAblate 2100DEVICE

Conformal Bone System

Exablate treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women age 18 and older
  • Patients who are able and willing to give consent and able to attend all study visits
  • Patients who are suffering from symptoms of bone metastases
  • 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)
  • Patient with NRS (0-10 scale) pain score ≥ 4 at the targeted tumors irrespective of medication.
  • Patient who's targeted tumors are on bone and bone-lesion interface is more than 1cm from the skin, major nerve or hollow viscera.
  • Targeted tumors clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible
  • Able to communicate sensations during the ExAblate MRgFUS treatment

You may not qualify if:

  • Patients who either:
  • Need surgical stabilization of the affected weight bearing bony structure OR
  • Targeted tumor is at an impending fracture site of the weigh bearing bone. OR
  • Patients with surgical stabilization of tumor site with metallic hardware
  • Target tumors-bone interface is less then 1cm from nerve bundles, bowels, skin or bladder.
  • Targeted (most painful) tumors:
  • NOT visible by non-contrast MRI, OR
  • NOT accessible to ExAblate device
  • Targeted tumor is in the skull
  • Patients on dialysis
  • Patients with life expectancy \< 6-Months
  • Patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study.
  • Subjects with Patients with unstable cardiac status including:
  • Unstable angina pectoris on medication
  • Patients with documented myocardial infarction less than 40 days prior to protocol enrolment
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba MC

Ramat Gan, 52621, Israel

Location

Related Links

MeSH Terms

Conditions

Bone NeoplasmsPainNeoplasm MetastasisBreast NeoplasmsLung NeoplasmsProstatic NeoplasmsCancer PainNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBone DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplastic ProcessesPathologic ProcessesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2010

First Posted

March 12, 2010

Study Start

March 1, 2010

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

March 8, 2016

Record last verified: 2016-03

Locations

IL(1)