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MR Guided Focused Ultrasound Surgery of Metastatic Bone Tumors

Primary Purpose

Bone Metastases

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ExAblate 2000
Sponsored by
InSightec
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Metastases focused on measuring Bone Tumors, Bone Cancer, Prostate Cancer, lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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) Patients on anti-coagulation therapy or those with an underlying bleeding disorder. Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 3 hrs.) Patient whose lesion is < 10-mm from the skin Patients with < 2-Weeks since chemotherapy Patient with < 1-Month since radiation therapy Patients with life expectancy < 6-Months Patients with surgical stabilization of tumor site with metallic hardware

Sites / Locations

  • University of California at San Diego
  • Toronto General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ExAblate MRgFUS

Arm Description

Outcomes

Primary Outcome Measures

Determine safety of MRgFUS of Bone Metastases

Secondary Outcome Measures

Full Information

First Posted
July 6, 2006
Last Updated
September 13, 2012
Sponsor
InSightec
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1. Study Identification

Unique Protocol Identification Number
NCT00350233
Brief Title
MR Guided Focused Ultrasound Surgery of Metastatic Bone Tumors
Official Title
MR Guided Focused Ultrasound Surgery of Metastatic Bone Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InSightec

4. Oversight

5. Study Description

Brief Summary
The objective of this trial is to evaluate the safety and effectiveness of MRgFUS in the treatment of metastatic bone tumors.
Detailed Description
Bone is the third most common organ involved by metastasic disease behind lung and liver. In breast cancer, bone is the second most common site of metastatic spread, and 90% of patients dying of breast cancer have bone metastasis. Breast and prostate cancer metastasize to bone most frequently, which reflects the high incidence of both these tumors, as well as their prolonged clinical courses. Post cancer survival has increased with improvement in early detection and treatments. As a consequence, the number of patients developing metastatic bone disease during their lifetime has also increased. Patients with bone metastasis from breast cancer have an average 2-year survival from the time of presentation with their first bone lesion. In patients who die from breast, prostate, and lung cancer, autopsy studies have shown that up to 85% have evidence of bone metastases at the time of death. Current treatments for patients with bone metastases are primarily palliative and include localized therapies (radiation and surgery), systemic therapies (chemotherapy, hormonal therapy, radiopharmaceutical, and bisphosphanates), and analgesics (opioids and non-steroidal anti-inflammatory drugs). Recently, radiofrequency ablation has been tested as a treatment option for bone metastases. The main goals of these treatments are improvement of quality of life and functional level. These goals can be further described: 1) Pain relief, 2) Preservation and restoration of function, 3) Local tumor control, 4) Skeletal stabilization. The study hypothesis is that MRgFUS is a safe and potentially effective non-invasive treatment for metastatic bone tumors with a low incidence of co-morbidity. Based on the result of this study the Sponsor will initiate a larger study in an effort to approve metastatic bone tumors as an indication for its MRgFUS ExAblate device.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Metastases
Keywords
Bone Tumors, Bone Cancer, Prostate Cancer, lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ExAblate MRgFUS
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
ExAblate 2000
Primary Outcome Measure Information:
Title
Determine safety of MRgFUS of Bone Metastases
Time Frame
Within 1 month of Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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) Patients on anti-coagulation therapy or those with an underlying bleeding disorder. Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 3 hrs.) Patient whose lesion is < 10-mm from the skin Patients with < 2-Weeks since chemotherapy Patient with < 1-Month since radiation therapy Patients with life expectancy < 6-Months Patients with surgical stabilization of tumor site with metallic hardware
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Chung, M.D.
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Gianfelice, M.D.
Organizational Affiliation
Toronto General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California at San Diego
City
LaJolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
MG5 2C4
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.insightec.com
Description
Sponsor Web Page

Learn more about this trial

MR Guided Focused Ultrasound Surgery of Metastatic Bone Tumors

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