International Trial of a Medical Device for the Treatment of Lung Cancer

Challenge

An international clinical trial evaluated a medical device designed to treat lung cancer. Device-based tumor treatment produces local tissue changes, including consolidation, cavitation and fibrosis, that evolve over months and can be confused with residual or recurrent tumor on both CT and PET. Response assessment therefore required criteria adapted to a local therapy rather than conventional systemic RECIST alone.

The sponsor selected Intrinsic Imaging in part because of its ISO 13485 certification for medical device core lab services, and needed a charter, reader methodology and documentation standard that would satisfy device regulators across the participating regions.

Intrinsic Imaging’s Solution

Intrinsic Imaging developed the protocol imaging section and charter with contrast-enhanced chest CT and PET/CT acquisition standards and a local response framework combining size, density and metabolic criteria, with explicit rules for distinguishing expected post-treatment change from local progression. Sites were qualified, trained and supported through centralized image transfer, blinding and processing.

Thoracic and oncology radiologists performed blinded independent reads of the treated lesion and of regional and distant disease, with adjudication of discordant local response classifications. Device-related findings such as pneumothorax, effusion and airway change were captured under safety definitions in the charter.

Quality control at receipt verified contrast phase, coverage and PET acquisition parameters, and the local control dataset was delivered with the safety imaging findings for the sponsor's regulatory submissions.

Intrinsic Imaging’s Results

• Approximately 210 treated patients at 24 sites in 7 countries assessed under a local response framework combining CT and PET criteria
• Expected post-treatment change distinguished from local progression under documented rules, with adjudication on discordant classifications
• Device-related imaging safety findings captured under predefined definitions for every post-procedure examination
• Documentation produced under an ISO 13485 certified quality system for medical device core lab services