Questions for the Panel to Consider: Devices for Ablation of Lung Tumors:
- Please discuss where you believe that ablation as
a means of local control may fit into the current armamentarium of
treatments for lung cancer. Local
control may mean reduction, stabilization or a decrease in the growth of
tumor size. Please describe the
specific patients for which this treatment may be appropriate, in terms of
extent of disease, size of the tumor(s), and evidence of failure of other
- Please discuss what you believe to be the
appropriate endpoints for a study to demonstrate the effectiveness of
ablation devices for the treatment of primary and secondary lung
malignancies, e.g., increase in survival, reduction in tumor size,
improvement in symptoms, improvement in quality of life.
- Please discuss the imaging modalities that you
believe would be appropriate to assess tumor size during these studies.
- The duration of follow-up should allow FDA to
adequately assess the safety and effectiveness of treatment with these
devices. Please comment on what
you believe to be the appropriate duration of follow-up for a pivotal
clinical study for these devices.
Please describe the
appropriate control group, endpoints and duration of follow-up for a clinical
study of an ablation device that is to be used in place of surgical resection
of lung tumors for patients who would be considered operable.