A Phase IV Post Approval Clinical Study of ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain

NCT01833806 | Completed Results

• 2 other identifiers: BM018P110039/S2
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 9

Brief Summary

The study hypotheses is that the proportion of patients experiencing clinically significant pain relief will be at least 30% greater than the proportion experiencing worsening pain.

Conditions

Bone Metastasis

Outcome Measures

Primary Outcomes (1)

• Proportion of Responders

  The statistical hypothesis is that the proportion of responders will be significantly greater than the proportion of subjects experiencing pain progression (worsened pain or increased pain medications usage). Using the Numerical Rating Score (NRS) for pain (0 being no pain and 10 being worst imaginable pain), subjects were rated as a Responder or as having Pain Progression. A responder is defined as a subject with a reduction in NRS worst score from baseline of two (2) or more points, and no increase in pain medication use. Pain Progression was increased pain of two (2) or more points.

  Three months post treatment

Other Outcomes (2)

• Numerical Rating Scale (NRS) for Pain Score

  Three months post treatment

• Quality of Life (QOL) as Measured by Change in Brief Pain Inventory - Interference (BPI) From Baseline

  Baseline, 1 Month post treatment, 2 Month post treatment, 3 Month post treatment.

Study Arms (1)

ExAblate Test Arm

EXPERIMENTAL

Focused Ultrasound Surgery delivered by ExAblate MRgFUS

Device: ExAblate MRgFUS

Interventions

ExAblate MRgFUS DEVICE

Focused Ultrasound Ablation

Also known as: Magnetic Resonance guided Focused Ultrasound Surgery

ExAblate Test Arm

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 or multiple myeloma bone lesions:
• Patients who have received radiation without adequate relief from metastatic bone pain as determined by the patient and treating physician
• those for whom their treating physician would not prescribe radiation or additional radiation treatments
• patients who refuse additional radiation therapy.
• Patient with NRS (0-10 scale) pain score ≥ 4 irrespective of medication
• Targeted bone/tumor interface 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 bone/tumor interface (most painful lesion) size up to 55 cm2 in surface area
• Patient whose targeted (treated) lesion is on bone and the interface between the bone and lesion is deeper than 10-mm from the skin.
• Targeted (treated) tumor clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible
• Able to communicate sensations during the ExAblate treatment
• Patients on ongoing chemotherapy regimen at the time of eligibility:
• with same chemotherapy regime (as documented from patient medical dossier), And
• Worst pain NRS still ≥ 4 And

You may not qualify if:

• Patients who either
• Need surgical stabilization of the affected bony structure (\>7 fracture risk score, see Section 7.4) OR
• Targeted tumor is at an impending fracture site (\>7 on fracture risk score, see Section 7.4).
• Patients with surgical stabilization of tumor site with metallic hardware
• More than 5 painful lesions, or more than 1 requiring immediate localized treatment
• Targeted (treated) tumor is in the skull
• Patients on dialysis
• Patients with life expectancy \< 3-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
• Severe hypertension (diastolic BP \> 100 on medication)

Sponsors & Collaborators

• InSightec: lead

Study Sites (9)

City of Hope

Duarte, California, 91010, United States

Location

University of California Los Angeles

Los Angeles, California, 90024, United States

Location

University of California San Francisco

San Francisco, California, 94107, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Weill Cornell Medical Center

New York, New York, 10065, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MD Anderson

Houston, Texas, 77030, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Results Point of Contact

• Title: Nadir Alikacem, VP Global Regulated Clinical Affairs & CRO
• Organization: Insightec

nadira@insightec.com

(214) 630-2000

Publication Agreements

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

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: April 12, 2013
• First Posted: April 17, 2013
• Study Start: September 1, 2013
• Primary Completion: January 14, 2022
• Study Completion: January 14, 2022
• Last Updated: April 7, 2023
• Results First Posted: April 7, 2023

Record last verified: 2023-04

Locations

US (9)