Clinical Trial: Liver Cancer Ablation Under Accublate Guidance
The single arm study took place at the Dartmouth Hitchcock Medical Center recruiting, under IRB approval and informed consent, 52 patients undergoing liver RF Ablation (RFA) to treat HCC. Patients admitted to the study had tumors of 2cm to 5cm in size. Accublate RF sim was used to support targeting of the tissues to be ablated; the trial was designed to test the hypothesis that with Accublate physicians can more consistently destroy the whole volume of the tumor, without leaving behind untreated portions of the tumor, a situation which would lead to a local recurrence (recurrence at a location of the liver where a tumor was already treated).
Some patients had multiple tumors, a total of 68 tumors were treated in the study. The main outcome measured by the study is the local recurrence rate. Patients are observed for a period of 24 months after treatment, to detect possible recurrences. As of March 2023, patients have been observed, on average, for 523 days. A Kaplan Meier analysis indicates a local recurrence rate at 12 months of 3.9%. This compares favorably to the benchmark recurrence rate of 12.7% reported in the study [1], indicating that Accublate RF Sim can reduce local recurrence rate by 3.4x compared to percutaneous ablation approaches under traditional image guidance, where no computer generated information is provided as an aid to the physician. The study [1] was selected as benchmark as it has the same tumor size distribution as our study (2cm to 5cm, with mean 2.7cm) and, despite being a 2010 study, it is still representative of today’s image guided approaches which most physicians adopt in US (CT guidance, manual insertion of the needle, and use of manufacturer’s kill-chart to determine the footprint of the ablation).
Comparison of Accublate RF Sim efficacy to modern stereotactic approaches with computer aidance is also favorable. The study [2], where CAS One IR, a surgical navigation / ablation support system, was used to guide percutaneous liver cancer Microwave Ablation (MWA), a similar procedure to RFA, reports a rate of incomplete ablation of 12.1% at 3-months follow-up.
In addition to the leading efficacy results, Accublate RF Sim did not present adverse events.
We would like to additionally highlight the leading nature of this work: the trial conducted by NES with Accublate RF Sim, was the first study world-wide where the real-time ablation simulation technology was used for decision making during the procedure.
NE Scientific’s Publications
Clinical trial results have been published in March 2024 on the Int. Journal of Hyperthermia:
References
[1] Kim YS, Lee WJ, Rhim H, Lim HK, Choi D, Lee JY. The minimal ablative margin of radiofrequency ablation of hepatocellular carcinoma (> 2 and < 5 cm) needed to prevent local tumor progression: 3D quantitative assessment using CT image fusion. AJR Am J Roentgenol. 2010 Sep;195(3):758–65
[2] Lachenmayer A, Tinguely P, Maurer MH, et al (2019) Stereotactic Image‐Guided Microwave Ablation of Hepatocellular Carcinoma Using a Computer‐Assisted Navigation System. Liver Int 39:1975–1985