First-in-man histotripsy of hepatic tumors: the THERESA trial, a feasibility study
Rationale 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 u...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Taylor & Francis Group
2022-12-01
|
| Series: | International Journal of Hyperthermia |
| Subjects: | |
| Online Access: | https://www.tandfonline.com/doi/10.1080/02656736.2022.2112309 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849317160955936768 |
|---|---|
| author | Joan Vidal-Jove Xavier Serres Eli Vlaisavljevich Jon Cannata Alex Duryea Ryan Miller Xavier Merino Manuela Velat Yossi Kam Ryan Bolduan Joseph Amaral Timothy Hall Zhen Xu Fred T. Lee Timothy J. Ziemlewicz |
| author_facet | Joan Vidal-Jove Xavier Serres Eli Vlaisavljevich Jon Cannata Alex Duryea Ryan Miller Xavier Merino Manuela Velat Yossi Kam Ryan Bolduan Joseph Amaral Timothy Hall Zhen Xu Fred T. Lee Timothy J. Ziemlewicz |
| author_sort | Joan Vidal-Jove |
| collection | DOAJ |
| description | Rationale 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 1.4 cm. 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. Trial Registration: Study to Evaluate VORTX Rx (Theresa). NCT03741088. https://clinicaltrials.gov/ct2/show/NCT03741088 KEY POINTSHistotripsy, a new noninvasive, non-thermal, non-ionizing focused ultrasound therapy, safely created a zone of tissue destruction in the liver that correlated very well with the pre-defined planned tissue destruction volume.In this first human trial histotripsy was well tolerated with no histotripsy device-related adverse events and its primary endpoint of acute technical success was achieved in all 8 enrolled patients with primary or secondary liver tumors.This new locoregional therapy for patients with liver tumors is safe and effective, warranting further trials. |
| format | Article |
| id | doaj-art-ce91c8ab6b4244dcb1db9a25e36031da |
| institution | Kabale University |
| issn | 0265-6736 1464-5157 |
| language | English |
| publishDate | 2022-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | International Journal of Hyperthermia |
| spelling | doaj-art-ce91c8ab6b4244dcb1db9a25e36031da2025-08-20T03:51:18ZengTaylor & Francis GroupInternational Journal of Hyperthermia0265-67361464-51572022-12-013911115112310.1080/02656736.2022.2112309First-in-man histotripsy of hepatic tumors: the THERESA trial, a feasibility studyJoan Vidal-Jove0Xavier Serres1Eli Vlaisavljevich2Jon Cannata3Alex Duryea4Ryan Miller5Xavier Merino6Manuela Velat7Yossi Kam8Ryan Bolduan9Joseph Amaral10Timothy Hall11Zhen Xu12Fred T. Lee13Timothy J. Ziemlewicz14Institute Khuab for Interventional Oncology, Comprehensive Tumor Center, Barcelona, SpainDepartment of Interventional Ultrasound, Vall d’Hebron University Hospital, Barcelona, SpainDepartment of Biomedical Engineering, Virginia Polytechnic University, Blacksburg, VirginiaResearch and Development, Histosonics, Inc, Ann Arbor, MI, USAResearch and Development, Histosonics, Inc, Ann Arbor, MI, USAResearch and Development, Histosonics, Inc, Ann Arbor, MI, USADepartment of Interventional Ultrasound, Vall d’Hebron University Hospital, Barcelona, SpainInstitute Khuab for Interventional Oncology, Comprehensive Tumor Center, Barcelona, SpainR&D Clinical Excellence, Philips Healthcare, Haifa, IsraelClinical Research and Medical Affairs, Histosonics, Inc, Ann Arbor, MI, USAClinical Research and Medical Affairs, Histosonics, Inc, Ann Arbor, MI, USADepartment of Biomedical Engineering, University of Michigan, Ann Arbor, MI, USADepartment of Biomedical Engineering, University of Michigan, Ann Arbor, MI, USADepartment of Radiology, University of Wisconsin, Madison, WI, USADepartment of Radiology, University of Wisconsin, Madison, WI, USARationale 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 1.4 cm. 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. Trial Registration: Study to Evaluate VORTX Rx (Theresa). NCT03741088. https://clinicaltrials.gov/ct2/show/NCT03741088 KEY POINTSHistotripsy, a new noninvasive, non-thermal, non-ionizing focused ultrasound therapy, safely created a zone of tissue destruction in the liver that correlated very well with the pre-defined planned tissue destruction volume.In this first human trial histotripsy was well tolerated with no histotripsy device-related adverse events and its primary endpoint of acute technical success was achieved in all 8 enrolled patients with primary or secondary liver tumors.This new locoregional therapy for patients with liver tumors is safe and effective, warranting further trials.https://www.tandfonline.com/doi/10.1080/02656736.2022.2112309Ablationhepatocellular carcinoma (HCC)liver metastasishistotripsyfocused ultrasoundtherapeutic ultrasound |
| spellingShingle | Joan Vidal-Jove Xavier Serres Eli Vlaisavljevich Jon Cannata Alex Duryea Ryan Miller Xavier Merino Manuela Velat Yossi Kam Ryan Bolduan Joseph Amaral Timothy Hall Zhen Xu Fred T. Lee Timothy J. Ziemlewicz First-in-man histotripsy of hepatic tumors: the THERESA trial, a feasibility study International Journal of Hyperthermia Ablation hepatocellular carcinoma (HCC) liver metastasis histotripsy focused ultrasound therapeutic ultrasound |
| title | First-in-man histotripsy of hepatic tumors: the THERESA trial, a feasibility study |
| title_full | First-in-man histotripsy of hepatic tumors: the THERESA trial, a feasibility study |
| title_fullStr | First-in-man histotripsy of hepatic tumors: the THERESA trial, a feasibility study |
| title_full_unstemmed | First-in-man histotripsy of hepatic tumors: the THERESA trial, a feasibility study |
| title_short | First-in-man histotripsy of hepatic tumors: the THERESA trial, a feasibility study |
| title_sort | first in man histotripsy of hepatic tumors the theresa trial a feasibility study |
| topic | Ablation hepatocellular carcinoma (HCC) liver metastasis histotripsy focused ultrasound therapeutic ultrasound |
| url | https://www.tandfonline.com/doi/10.1080/02656736.2022.2112309 |
| work_keys_str_mv | AT joanvidaljove firstinmanhistotripsyofhepatictumorsthetheresatrialafeasibilitystudy AT xavierserres firstinmanhistotripsyofhepatictumorsthetheresatrialafeasibilitystudy AT elivlaisavljevich firstinmanhistotripsyofhepatictumorsthetheresatrialafeasibilitystudy AT joncannata firstinmanhistotripsyofhepatictumorsthetheresatrialafeasibilitystudy AT alexduryea firstinmanhistotripsyofhepatictumorsthetheresatrialafeasibilitystudy AT ryanmiller firstinmanhistotripsyofhepatictumorsthetheresatrialafeasibilitystudy AT xaviermerino firstinmanhistotripsyofhepatictumorsthetheresatrialafeasibilitystudy AT manuelavelat firstinmanhistotripsyofhepatictumorsthetheresatrialafeasibilitystudy AT yossikam firstinmanhistotripsyofhepatictumorsthetheresatrialafeasibilitystudy AT ryanbolduan firstinmanhistotripsyofhepatictumorsthetheresatrialafeasibilitystudy AT josephamaral firstinmanhistotripsyofhepatictumorsthetheresatrialafeasibilitystudy AT timothyhall firstinmanhistotripsyofhepatictumorsthetheresatrialafeasibilitystudy AT zhenxu firstinmanhistotripsyofhepatictumorsthetheresatrialafeasibilitystudy AT fredtlee firstinmanhistotripsyofhepatictumorsthetheresatrialafeasibilitystudy AT timothyjziemlewicz firstinmanhistotripsyofhepatictumorsthetheresatrialafeasibilitystudy |