ExAblate Conformal Bone System Treatment of Metastatic Bone Tumors for the Palliation of Pain

NCT00981578 | Terminated Results

• 1 other identifier: BM010
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 5

Brief Summary

A study to evaluate the safety and initial effectiveness of the ExAblate 2100 Conformal Bone System in the treatment of pain resulting from metastatic bone tumors.

Conditions

Bone Metastases

Keywords

bone cancer; pain palliation; metastasis; breast cancer; lung cancer; prostate cancer; cancer related pain; tumors

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Device Effects

  Adverse effects outcomes are reported in the adverse events module.

  3 months

Secondary Outcomes (2)

• Change in NRS Pain Scores From Baseline at 3 Months

  Baseline, 3 months

• Change Brief Pain Inventory - Pain Interference From Baseline at 3 Months

  Baseline, 3 months

Study Arms (1)

ExAblate 2100 Treatment

EXPERIMENTAL

ExAblate 2100 ablation for the treatment of painful bone metastases.

Device: ExAblate 2100

Interventions

ExAblate 2100 DEVICE

Conformal Bone System

Also known as: Focused ultrasound ablation, MRgFUS

ExAblate 2100 Treatment

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 consent and able to attend all study visits
• Patients who are suffering from symptoms of bone metastases
• One to 3 painful lesions.
• 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)
• Patients with persistent distinguishable pain associated with up to 3 tumors of which a maximum of 2 tumors will be treated:
• o If patient has pain from additional sites that are not planned for treatment, the pain from the additional sites must be evaluated as being less intense by at least 2 points on the NRS compared to the site(s) to be treated.
• Patient with NRS (0-10 scale) pain score ≥ 4 at the targeted tumors (i.e: both tumors targeted for treatment must have NRS ≥ 4) irrespective of medication
• Targeted tumors (most painful) size up to 8 cm in diameter
• Patient whose targeted (most painful) tumors are on bone and bone-lesion interface is deeper than 1cm from the skin.
• Targeted (most painful) tumors clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible
• Able to communicate sensations during the ExAblate MRgFUS treatment
• At least 2 weeks since chemotherapy
• No radiation therapy to targeted (most painful) tumors in the past two weeks

You may not qualify if:

• Patients who either
• Need surgical stabilization of the affected weight bearing bony structure (\>7 fracture risk score, see Section 6.9) OR
• Targeted tumor is at an impending fracture site of the weigh bearing bone (\>7 on fracture risk score, see Section 6.9).
• o Patients with surgical stabilization of tumor site with metallic hardware
• More than 3 painful lesions or more than 2 requiring immediate localized treatment
• The targeted tumor(s) is (are) less than 2 points more painful compared to other non-targeted painful lesions on the site specific NRS.
• 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.
• 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

Sponsors & Collaborators

• InSightec: lead

Study Sites (5)

City of Hope

Duarte, California, 91010, United States

Location

University of California San Francisco

San Francisco, California, 94107, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Methodist Hospital Research Institute

Houston, Texas, 77030, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Links

• Sponsor's web page

MeSH Terms

Conditions

Bone Neoplasms; Neoplasm Metastasis; Breast Neoplasms; Lung Neoplasms; Prostatic Neoplasms; Cancer Pain; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms

Limitations and Caveats

The study was terminated early leading to small numbers of subjects analyzed. The study was designed to enroll 50 subjects. Enrollment was terminated after enrolling 17 subjects.

Results Point of Contact

• Title: Nadir Alikacem
• Organization: InSightec

nadira@insightec.com

214.360.2000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: September 21, 2009
• First Posted: September 22, 2009
• Study Start: September 1, 2009
• Primary Completion: November 14, 2016
• Study Completion: November 14, 2016
• Last Updated: March 11, 2020
• Results First Posted: March 11, 2020

Record last verified: 2020-03

Locations

US (5)