Histotripsy – pro

Histotripsy is the first noninvasive, non-ionizing, and non-thermal ablation technology guided by real-time imaging. Using focused ultrasound delivered from outside the body, histotripsy mechanically destroys tissue through cavitation, rendering the target into acellular debris. The material in the histotripsy ablation zone is absorbed by the body within 1–2 months, leaving a minimal remnant scar. Histotripsy has also been shown to stimulate an immune response and induce abscopal effects in animal models, which may have positive implications for future cancer treatment. Histotripsy has been investigated for a wide range of applications in preclinical studies, including the treatment of cancer, neurological diseases, and cardiovascular diseases. Three human clinical trials have been undertaken using histotripsy for the treatment of benign prostatic hyperplasia, liver cancer, and calcified valve stenosis.

In 2022, a study , Theresa, established feasibility of this treatment. A multicenter phase I trial (Theresa Study) was performed in a single country with 8 weeks of planned follow-up, and ti included 8 patients who all had unresectable end-stage multifocal liver tumors: colorectal liver metastases (CRLM) in 5 patients (7 tumors), breast cancer metastases in 1 (1 tumor), cholangiocarcinoma metastases in 1 (2 tumors), and hepatocellular carcinoma (HCC) in 1 (1 tumor). This first-in-human trial demonstrates that hepatic histotripsy effectively destroys liver tissue in a predictable manner, correlating very well with the planned histotripsy volume, and has a high safety profile without any device-related adverse events. Based on these results, the need for more definitive clinical trials is warranted.

This modality is being explored as a potential treatment for colorectal cancer that has spread to the liver (metastatic colorectal cancer). It works by generating microbubbles within the tumor that then collapse and liquify the cancerous tissue. Forty-four participants with 49 tumors were enrolled in the #HOPE4LIVER trial between the United States and Europe.

After treatment, technical success was achieved in 95% of cases (42 of 44), eclipsing the performance goal of 70%. In addition, three of the 44 cases reported a procedure-related major complication, below the 25% goal for safety, of which at least two may have been cancer- related and not device related, as reported by Mendiratta-Lala.

A review by Sandilos et concluded: ” As with most novel therapies, the effect of histotripsy on the oncologic therapeutic landscape remains uncertain. “.

It is still an E?I treatment.

Xu Z, Hall TL, Vlaisavljevich E, Lee FT Jr. Histotripsy: the first noninvasive, non-ionizing, non-thermal ablation technique based on ultrasound. Int J Hyperthermia. 2021;38(1):561-575. doi: 10.1080/02656736.2021.1905189. PMID: 33827375; PMCID: PMC9404673.

Verma Y, Arachchige ASPM. Revolutionizing cardiovascular care: the power of histotripsy. J Ultrasound. 2024 Dec;27(4):759-768. doi: 10.1007/s40477-023-00848-7. Epub 2024 Jan 13. PMID: 38217765; PMCID: PMC11496427.

Sandilos G, Butchy MV, Koneru M, Gongalla S, Sensenig R, Hong YK. Histotripsy – hype or hope? Review of innovation and future implications. J Gastrointest Surg. 2024 Aug;28(8):1370-1375. doi: 10.1016/j.gassur.2024.05.038. Epub 2024 Jun 9. PMID: 38862075.

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