Negotiating a Trial Contract and Convincing the Industry

In this episode, Dr. Constantinos (Costi) Sofocleous, Dr. Bruno Odisio, and Dr. William Rilling discuss the history of percutaneous liver tumor ablation, takeaways from past and present clinical studies, and the contemporary role of ablation margin confirmation software for optimizing treatment outcomes.

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SHOW NOTES

Costi initiates the discussion by highlighting crucial developments in tumor ablation over the last 15 years. He notes that it took time to realize that tumors larger than 3 cm carried higher rates of local failure, primarily due to insufficient margins. Research eventually found that establishing larger margins, preferably 10 mm margins, resulted in significantly lower recurrence rates. In fact, with these margins, ablation outcomes became even more favorable than surgical outcomes. This shift towards personalizing the approach to each tumor has been instrumental in improving patient outcomes.

The conversation then transitions to innovation within the realm of ablation. There are fewer prospective studies over ablation as a sole treatment, since ablation is often performed in conjunction with surgery. Additionally, the presence of numerous vendors for ablation technology makes it challenging to conduct comprehensive studies.

The doctors also discuss the importance of ablation margins and recurrence. 3D confirmation is correlated with greater control over the procedure. Local recurrence tends to occur in areas where the margin is suboptimal, but the exact standards for what constitutes "suboptimal" margins are yet to be established. Nevertheless, the consensus among experts is that a contrast CT on the day of the ablation and a subsequent 3D evaluation of the images are crucial. This evaluation should be repeated three weeks later to verify the success of the procedure. Costi mentions that at Memorial Sloan Kettering, ablation zone biopsy is an option if necessary, which adds another layer of verification.

The discussion also touches on the importance of using a guidance system for ablation. Bruno underlines the significance of always using CT to verify the procedure. He points out that colleagues in Europe have been using stereotactic guidance for many years, revealing that 40% of the time, the ablation application wasn't placed exactly where they thought it would be based on pre-scans. This is where stereotactic technology becomes invaluable. Costi suggests real-time PET as a beneficial tool, but the challenge lies in justifying these additional steps to payers. Minimum imaging requirements and margin confirmation software are essential components of a guidance system..

The episode culminates in a discussion of a significant trial that involves three different industry sponsors - a landmark effort in the field of oncology. The ACCLAIM trial, which began in 2016, sought to conduct a multicenter study but took four years to secure approval and funding. Costi highlights the reasons for its success, emphasizing the potential for reproducible outcomes that could establish ablation as a strong indication in colorectal cancer. The data suggests that margin confirmation software significantly improves margins, and he hopes that this information will lead to increased reimbursement for the use of these crucial software tools.

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RESOURCES

ACCLAIM Trial:

https://www.sio-central.org/Research-Resources/Research-Grants/ACCLAIM-Trial