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

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dc.contributor.authorVidal-Jove, Joanen
dc.contributor.authorSerres, Xavieren
dc.contributor.authorVlaisavljevich, Elien
dc.contributor.authorCannata, Jonen
dc.contributor.authorDuryea, Alexen
dc.contributor.authorMiller, Ryanen
dc.contributor.authorMerino, Xavieren
dc.contributor.authorVelat, Manuelaen
dc.contributor.authorKam, Yossien
dc.contributor.authorBolduan, Ryanen
dc.contributor.authorAmaral, Josephen
dc.contributor.authorHall, Timothyen
dc.contributor.authorXu, Zhenen
dc.contributor.authorLee, Fred T., Jr.en
dc.contributor.authorZiemlewicz, Timothy J.en
dc.date.accessioned2022-10-04T16:46:23Zen
dc.date.available2022-10-04T16:46:23Zen
dc.date.issued2022-12-31en
dc.description.abstractRationale Current hepatic locoregional therapies are limited in terms of effectiveness and toxicities. Given promising pre-clinical results, a first in-human trial was designed to assess the technical effectiveness and safety profile of histotripsy, a noninvasive, non-thermal, non-ionizing focused ultrasound therapy that creates precise, predictable tissue destruction, in patients with primary and secondary liver tumors. Methods A multicenter phase I trial (Theresa Study) was performed in a single country with 8 weeks of planned follow-up. Eight of fourteen recruited patients were deemed eligible and enrolled in the study. Hepatic histotripsy, was performed with a prototype system (HistoSonics, Inc., Ann Arbor, MI). Eleven tumors were targeted in the 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). The primary endpoint was acute technical success, defined as creating a zone of tissue destruction per planned volume assessed by MRI 1-day post-procedure. Safety (device-related adverse events) through 2 months was a secondary endpoint. Results The 8 patients had a median age of 60.4 years with an average targeted tumor diameter of 1.4cm. The primary endpoint was achieved in all procedures. The secondary safety profile endpoint identified no device-related adverse events. Two patients experienced a continuous decline in tumor markers during the eight weeks following the procedure. Conclusions 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.en
dc.description.versionPublished versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.doihttps://doi.org/10.1080/02656736.2022.2112309en
dc.identifier.eissn1464-5157en
dc.identifier.issn0265-6736en
dc.identifier.issue1en
dc.identifier.pmid36002243en
dc.identifier.urihttp://hdl.handle.net/10919/112067en
dc.identifier.volume39en
dc.language.isoenen
dc.publisherTaylor & Francisen
dc.rightsCreative Commons Attribution 4.0 Internationalen
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en
dc.subjectAblationen
dc.subjecthepatocellular carcinoma (HCC)en
dc.subjectliver metastasisen
dc.subjecthistotripsyen
dc.subjectfocused ultrasounden
dc.subjecttherapeutic ultrasounden
dc.titleFirst-in-man histotripsy of hepatic tumors: the THERESA trial, a feasibility studyen
dc.title.serialInternational Journal of Hyperthermiaen
dc.typeArticle - Refereeden
dc.type.dcmitypeTexten

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