A Phase IV Post Approval Clinical Study of ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Phase IV Post Approval Clinical Study of ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain|
- Proportion of Responders [ Time Frame: Three months ] [ Designated as safety issue: No ]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) by at least 30% or an odds ratio of at least 2.
- Safety Profile [ Time Frame: Three Months ] [ Designated as safety issue: Yes ]A full safety profile will be developed for the ExAblate treatment of bone metastases. All adverse events will be captured and summarized as defined in Section-6.2. Adverse events (type, frequency, severity) are expected to be similar to those captured for the original PMA study (PMA # P110039). For his study, the Safety comparison will be descriptive with no statistical endpoints.
- Pain Interference [ Time Frame: Three Months ] [ Designated as safety issue: No ]Patient overall quality of life status will be assessed by the BPI-QoL Pain Interference scale which will be administered pre-treatment and post-treatment. The trajectory of change may be analyzed descriptively by regression slopes.
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Experimental: ExAblate Test Arm
Focused Ultrasound Surgery delivered by ExAblate MRgFUS
Device: ExAblate MRgFUS
Focused Ultrasound Ablation
Other Name: Magnetic Resonance guided Focused Ultrasound Surgery
As part of the PMA # P110039 review process and approval, InSightec was requested to conduct a post-approval study. Patients will be treated following the approved commercial treatment guidelines.
For this study, participating sites will use the ExAblate device for the administration of the ExAblate treatment. This study will be performed on either 1.5T or 3T MR scanners.
For this study, a total of 70 patients meeting the approved commercial guidelines will be enrolled and treated with the ExAblate system at from 7 to 10 sites. The proportion of responders is expected to be at least 30% greater than the proportion of subjects experiencing pain progression (i.e., 60% vs. 30%). Additionally, at the 3 month visit, an analysis of both the safety and efficacy profiles will be compared to the original PMA pivotal study group.
|United States, California|
|University of California San Francisco||Recruiting|
|San Francisco, California, United States, 94107|
|Contact: Stephanie Murphy 415-353-9446 email@example.com|
|Principal Investigator: Thomas Link, M.D.|