Interventional Device Trial for Percutaneous Tumor Ablation

Challenge

A developer of a percutaneous tumor ablation device required imaging evidence of technical success and durable local tumor control for primary and metastatic tumors. Assessment of ablation zones is multimodal and time-dependent: the zone evolves over months, benign periablational enhancement can mimic residual tumor, and the margins that predict local recurrence must be measured in three dimensions against the pre-procedure tumor.

The sponsor had not yet fixed its imaging endpoints and needed expert guidance on which measurements would be reproducible, which timepoints would be informative, and how to acquire images so that pre- and post-ablation findings could be compared reliably across sites and operators.

Intrinsic Imaging’s Solution

Intrinsic Imaging's interventional radiologists advised the sponsor on the imaging charter, recommending contrast-enhanced CT or MRI at defined post-ablation intervals, standardized acquisition parameters, and endpoints based on ablation zone volume, minimal ablative margin and local tumor progression. Sites were qualified and trained on the protocol, including the immediate post-procedure imaging used to confirm technical success.

Interventional radiologists performed blinded reads of pre-procedure, immediate post-procedure and follow-up imaging, measuring the tumor and ablation zone in three dimensions, computing the minimal margin and classifying enhancement patterns as expected periablational change, residual tumor or local progression under charter-defined criteria. Discordant classifications were adjudicated.

Image transfer, quality control and processing were centralized so that each patient's serial imaging was co-registered and complete before reading, and project managers tracked the follow-up schedule to protect the durability endpoint.

Intrinsic Imaging’s Results

• Imaging charter and endpoint definitions established with the sponsor before enrollment, giving the trial reproducible measures of technical success and local control
• Approximately 180 ablations at 14 sites assessed with three-dimensional ablation zone and minimal-margin measurement
• Periablational enhancement distinguished from residual or recurrent tumor under documented criteria with adjudication of discordant reads
• Follow-up imaging compliance above 92% at the 12-month timepoint through active schedule tracking