NCT00350233

Brief Summary

The objective of this trial is to evaluate the safety and effectiveness of MRgFUS in the treatment of metastatic bone tumors.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2006

Typical duration for phase_1

Geographic Reach
2 countries

2 active sites

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

May 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2006

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

September 17, 2012

Status Verified

September 1, 2012

Enrollment Period

3.8 years

First QC Date

July 6, 2006

Last Update Submit

September 13, 2012

Conditions

Bone Metastases

Keywords

Bone TumorsBone CancerProstate Cancerlung cancer

Outcome Measures

Primary Outcomes (1)

  • Determine safety of MRgFUS of Bone Metastases

    Within 1 month of Treatment

Study Arms (1)

ExAblate MRgFUS

EXPERIMENTAL
Device: ExAblate 2000

Interventions

ExAblate 2000DEVICE
ExAblate MRgFUS

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 with histologically or cytologically confirmed malignant disease with a bone lesion that appears to be metastatic disease by clinical and or imaging techniques
  • Must have persistent pain from at least one site of bone metastases
  • Patient with VAS pain score ≥ 4, when VAS test taken without medication, OR
  • Patient taking pain-relieving medication for management of bone metastases.
  • Targeted tumor(s) are ExAblate device accessible
  • Targeted tumor(s) size is smaller than 8 cm in diameter
  • 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
  • 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 weight bearing bones or impending fracture
  • Targeted tumor is in the vertebral column.
  • Patients with unstable cardiac status including:
  • Unstable angina pectoris on medication
  • Patients with documented myocardial infarction within six months of protocol entry
  • Congestive heart failure requiring medication (other than diuretic)
  • Patients 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 \>250 pounds), etc.
  • Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist)
  • ASA Score\>2 (See "Definitions" below)
  • 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)
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California at San Diego

La Jolla, California, 92037, United States

Location

Toronto General Hospital

Toronto, Ontario, MG5 2C4, Canada

Location

Related Links

MeSH Terms

Conditions

Bone NeoplasmsProstatic NeoplasmsLung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Christine Chung, M.D.

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

  • David Gianfelice, M.D.

    Toronto General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2006

First Posted

July 10, 2006

Study Start

May 1, 2006

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

September 17, 2012

Record last verified: 2012-09

Locations

CA(1)US(1)