First-in-man histotripsy of hepatic tumors: the THERESA trial, a feasibility study

Vidal-Jové, Joan; Serres, Xavier; Vlaisavljevich, Eli; Cannata, J.M.; Duryea, Alex; Miller, Ryan S.; Merino, Xavier; Velat, Manuela; Kam, Yossi; Bolduan, Ryan; Amaral, Joseph F.; Hall, Timothy J.; Xu, Zhen; Lee, Fred T.; Ziemlewicz, Timothy J.

doi:10.1080/02656736.2022.2112309

Cited by 74 publications

(36 citation statements)

References 33 publications

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“…A phase I clinical trial (NCT03741088) of liver histotripsy in patients with multifocal hepatic malignant tumors was conducted in Barcelona in 2019 (132). This trial also used a clinical prototype liver histotripsy device (23).…”

Section: Clinical Trial Of Histotripsy For Liver Cancermentioning

confidence: 99%

Research progress and clinical evaluation of histotripsy: a narrative review

Li¹,

Wei²,

Zhang³

et al. 2023

Ann Transl Med

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Background and Objective: As a soft-tissue noninvasive ablation technology, high-intensity focused ultrasound (HIFU) has been widely used to treat many clinical diseases. However, traditional HIFU, based on thermal effects, has a high local working temperature, which may cause thermal damage to surrounding tissues and reduce the therapeutic effect. Based on the cavitation effect of HIFU, histotripsy can mechanically destroy the cells in the target lesion. This paper aims to explain the mechanism of histotripsy, summarize the research progress of animal models for clinical evaluation and clinical application, and analyze the advantages and limitations of histotripsy.Methods: Literature published from January 2006 to March 2022 was retrieved from the PubMed database.We reviewed these articles to examine histotripsy from the aspects of the mechanism, animal experiments, clinical trials, advantages, disadvantages, and optimization.

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Section: Clinical Trial Of Histotripsy For Liver Cancermentioning

confidence: 99%

Research progress and clinical evaluation of histotripsy: a narrative review

Li¹,

Wei²,

Zhang³

et al. 2023

Ann Transl Med

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“…[9][10][11] Histotripsy does not appear to increase the risk of parenchymal haemorrhage, even in anticoagulated subjects. 12 To date, histotripsy has been applied in small clinical trials for the treatment of benign prostatic hyperplasia and malignant liver tumours, 13,14 and larger trials are currently planned or underway. Multiple future applications are being actively explored in preclinical models and include treatment of benign and malignant tissue in the liver, kidney, pancreas, brain, thyroid, subcutaneous fat, and blood vessels.…”

Section: What Is Histotripsy?mentioning

confidence: 99%

“…8,14,16 SUMMARY Histotripsy is a new focused US treatment modality that destroys targeted tissue through cavitation. US can be used for targeting, cavitation monitoring, and post-treatment assessment due to a co-axially mounted diagnostic transducer contained within the therapeutic transducer.…”

mentioning

confidence: 99%

Imaging for Targeting, Monitoring, and Assessment After Histotripsy: A Non-invasive, Non-thermal Therapy for Cancer

et al. 2023

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Hinshaw is a shareholder for HistoSonics, Elucent Medical, and Accure Therapeutics; and is a consultant for Ethicon/Neuwave. Laeseke has received research support from Histosonics; is a consultant for Histosonics, Ethicon, and Elucent Medical; and a shareholder for HistoSonics, Elucent Medical, McGinley Orthopedics, and RevOps Medical. Ziemlewicz has received research support from Histosonics and Ethicon; is a shareholder for Histosonics; and is a consultant for Ethicon and Elephas. Lee has received research support, is a shareholder, and is on the board of directors for Histosonics; is a consultant for Ethicon; is on the board of medical advisors for Canon; and has received patents and royalties from Medtronic. The other authors have declared no conflicts of interest.

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“…Histotripsy utilizes short, high amplitude ultrasound pulses to generate acoustic cavitation bubble clouds within a target tissue; the bubble cloud then expands and contracts, disintegrating the tissue into its subcellular components (Bader et al 2019;Vlaisavljevich et al 2016). Histotripsy treatment is typically guided in real-time by ultrasound imaging and can target a treatment area with millimeter precision (Lin et al 2014;Ruger et al 2022;Vidal-Jove et al 2022).…”

Section: Introductionmentioning

confidence: 99%

Histotripsy Ablation for the Treatment of Feline Injection Site Sarcomas: A First-in-Cat In Vivo Feasibility Study

Ruger¹,

Yang²,

Coutermarsh-Ott³

et al. 2023

Preprint

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<p>Feline soft tissue sarcoma (STS) and injection site sarcoma (fISS) are rapidly growing tumors with low metastatic potential, but locally aggressive behavior. Histotripsy is a non-invasive focused ultrasound therapy using controlled acoustic cavitation to mechanically disintegrate tissue. In this study, we investigated the <em>in vivo</em> safety and feasibility of histotripsy to treat fISS using a custom 1 MHz transducer. Three cats with naturally-occurring STS were treated with histotripsy before surgical removal of the tumor 3 to 6 days later. Gross and histological analyses were used to characterize the ablation efficacy of the treatment, and routine immunohistochemistry and batched cytokine analysis were used to investigate the acute immunological effects of histotripsy. Results showed that histotripsy ablation was achievable and well-tolerated in all three cats. Precise cavitation bubble clouds were generated in all patients, and hematoxylin & eosin stained tissues revealed ablative damage in targeted regions. Immunohistochemical results identified an increase in IBA-1 positive cells in treated tissues, and no significant changes in cytokine concentrations were identified post-treatment. Overall, the results of this study demonstrate the safety and feasibility of histotripsy to target and ablate superficial feline STS and fISS tumors and guide the clinical development of histotripsy devices for this application. </p>

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First-in-man histotripsy of hepatic tumors: the THERESA trial, a feasibility study

Cited by 74 publications

References 33 publications

Research progress and clinical evaluation of histotripsy: a narrative review

Research progress and clinical evaluation of histotripsy: a narrative review

Imaging for Targeting, Monitoring, and Assessment After Histotripsy: A Non-invasive, Non-thermal Therapy for Cancer

Histotripsy Ablation for the Treatment of Feline Injection Site Sarcomas: A First-in-Cat In Vivo Feasibility Study

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