Clinical trial NCT03741088: Study to Evaluate VORTX Rx (Theresa)
Official title: Multi-center, Open-labeled, Non-randomized Study to Evaluate the Acute Technical Performance and Safety Profile of the VORTX Rx® for Ablation of Primary and Metastatic Liver Tumors (Theresa Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carcinoma, Hepatocellular
Liver Metastases
Lead sponsor: HistoSonics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-14
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Multi-center, Open-labeled, Non-randomized Study to Evaluate the Acute Technical Performance and Safety Profile of the VORTX Rx® for Ablation of Primary and Metastatic Liver Tumors

Detailed description: The study will assess the technical performance of the VORTX Rx device to deliver acoustic energy for cavitation-based cellular destruction. The planned duration of a single target tumor will be 60 minutes or less in a single session and adjusted intra-procedurally as necessary per investigator discretion. Subjects in this study must have an adequate acoustic window in the abdominal space in order to be eligible for enrollment. All patients who undergo ablation with the investigation device will be treated in a hospital environment under general anesthesia not to exceed four hours.

Eligibility criteria: Inclusion Criteria:

* Written informed consent before any study procedure is performed.
* Subjects of both sexes aged 18 years or older.
* Patients diagnosed with liver cancer, including HCC or liver metastases from breast, pancreas and/or colorectal cancers. If biopsy is required, there will be a minimum of 2-week period after biopsy and before the ablation.
* HCC patients must meet the United Network for Organ Sharing and Organ Procurement and Transplantation Network (UNOS-OPTN) class 5 criteria for HCC (52).
* Liver metastases patients must meet minimum criteria of liver biopsy and/or tissue diagnosis of primary tumor or metastatic tumor with new or growing liver tumors radiologically consistent with metastases.
* Patients with liver cancer not candidates for surgical resection and/or not suitable for other locoregional treatments or patients who have not responded to or relapsed from conventional therapies.
* Previous treatment with chemotherapy and/or radiotherapy is permitted provided that these treatments have been discontinued more than 2 weeks before the ablation and whenever patients have recovered from any related toxicity (53).
* Previous treatment with immunotherapies is permitted provided that these therapies have been discontinued at least 4 weeks before the ablation and whenever patients have recovered from any related toxicity.
* Previous ablation/surgery on other tumors different from those that will be targeted with the VORTX Rx® is allowed whenever a minimum of 2 weeks has elapsed since the prior procedure(s).
* Tumor to be targeted for ablation will be clearly separated from other tumors or other critical areas (i.e. located in different segments of the liver) and located in segment 2, 3, 4, 5 or 6.
* Largest diameter of targeted tumor ≤3 cm.
* Tumor that will be targeted at a depth \<10 cm from the skin surface.
* Must have an adequate acoustic window in the abdominal space to be able to visualize targeted tumor using ultrasound imaging; also must be able to visualize targeted tumor using MRI with optional CT imaging at investigator discretion.
* Patients who can undergo general anesthesia.
* Liver function score of Child-Pugh A or Child-Pugh B.
* ECOG PS 0, 1 or 2 at screening.
* Adequate liver function (ALT and AST \< 2.5 x upper limit of normal \[ULN\]), renal function (serum creatinine \<2 ULN and/or bilirubin \<2.5 UNL) and hematologic function (neutrophil count \> 1.0 x 109/L and platelet \> 50 x 109/L).
* An INR \<2 within the last 7 days prior to the ablation in patients receiving anticoagulants, and an INR \<1.5 for patients not treated with anticoagulants.
* Platelets level \>50 x 109/L within the last 7 days prior to the ablation.

Exclusion Criteria:

* Patients who decline or are unable to understand, provide or are unwilling to sign an informed consent form.
* Pregnant or nursing (lactating) women; women of childbearing potential and sexually active that are unwilling to use adequate contraception (such as oral contraceptives, intrauterine contraceptive device or barrier method with spermicide or surgical sterilization).
* Targeted tumor not clearly separated (i.e. located in the same liver segment as another tumor).
* Targeted tumor located in liver segments 1, 7 or 8.
* Targeted tumor \>3 cm.
* Tumor that will be targeted \>10 cm from the skin surface.
* Tumor not clearly visible with diagnostic ultrasound and MRI.
* Liver function score of Child-Pugh C.
* Liver volume reserve \<40% as measured by CT Scan (54).
* Major surgical procedure, biopsy or significant traumatic injury \<2 weeks prior to the procedure or has not recovered from side effects/complications of such procedure or trauma.
* Patient who has not recovered to grade 1 or better from any AEs (except alopecia, fatigue, nausea, vomiting) related to previous anti neoplastic therapies.
* BMI \>30.
* Parkinson's disease.
* History of bleeding disorders (e.g. von Willebrand disease) or patients suspected to have a bleeding disorder.
* Not able to temporarily discontinue warfarin, clopidogrel or any other long-acting anticoagulants at least two weeks before the procedure.
* Initiation of any anticancer treatment during the screening period and during the follow-up study visits.
* Life expectancy to be less than 6 months.
* Unable or unwilling to complete all required screening and/or follow-up assessments.
* Patients under ongoing treatment with an investigational medication or medical device that conflicts with the study device.
* Patients for whom the investigator considers that the ablation is not in the patient's best interest.
* Patients with active alcohol or drug addiction or any other condition that, in the investigator's opinion, would interfere with their ability to comply with the study requirements.
* Patients with any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol.
* Patients with known sensitivity to iodine.

Primary outcomes:
measure: Acute Technical Performance of the VORTX Rx® Medical Device for the Ablation of Primary and Metastatic Liver Tumors
timeFrame: 1-day post ablation
Secondary outcomes:
measure: Safety Profile of the VORTX Rx. Incidence of Adverse Events (Serious and Non-serious) That Are Probably or Definitely Device-related
timeFrame: 2 months
measure: Local Tumor Progression
timeFrame: 1 week, 1 month and 2 months post-procedure.
measure: Involution of the Ablation Zone
timeFrame: 24hours, 1 week, 1 month and 2 months, post-procedure.
measure: Assessment of Liver panel_Part 1
timeFrame: Screening, 24 hours, 1 week, 1 month and 2 months.
measure: Assessment of Liver Panel_Part 2
timeFrame: 24 hours, 1 week and 1 month and 2 months
measure: Assessment of Liver Panel_Part 3
timeFrame: 24 hours, 1 week and 1month and 2 months
measure: Assessment of Liver Panel_part 4
timeFrame: 24 hours, 1 week and 1month and 2 months
measure: Assessment of Liver Panel_Part 5
timeFrame: 24 hours, 1 week and 1 month and 2 months
measure: Immunologic Assessment_Part 1
timeFrame: Baseline/Screening, 1-day post ablation, 1 week and 1 and 2 months post procedure
measure: Immunologic Assessment_Part 2
timeFrame: Screening, 24 hours, 1 week and 1 and 2 months post procedure.
measure: Immunologic Assessment_Part 3
timeFrame: Screening, 24 hours post ablation, 1 week and 1 and 2 months post procedure.
measure: Immunologic Assessment_Part 4
timeFrame: Screening, 24 hours post ablation, 1 week and 1 and 2 months post procedure.
measure: Immunologic Assessment_Part 5
timeFrame: Screening, 24 hours post ablation, 1 week and 1 and 2 months post procedure.
measure: Immunologic Assessment_Part 6
timeFrame: Screening, 24 hours post ablation, 1 week and 1 and 2 months post procedure.
measure: Assesment of Quality of Life by Using Patient Questtionaires EORTC QLQ-C30. (European Organization for Research and Treatment of Cancer)
timeFrame: Screening, 1 and 2 months post procedure.
measure: Pain Assessment by VAS Scale
timeFrame: 1-day post ablation and 1 week post procedure.
measure: Analgesic Requirements After the Ablation Procedure
timeFrame: in the 24-hour period post-procedure and during the one week period post-procedure
Other outcomes:
Locations:
city: Esplugues De Llobregat
country: Spain
facility: Clinica Diagonal
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital universitario Mutua Terrassa
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d´Hebrón
Study officials:
affiliation: Mutua Terrassa , Barcelona, Spain
name: Joan Vidal Jove, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vidal-Jove J, Serres X, Vlaisavljevich E, Cannata J, Duryea A, Miller R, Merino X, Velat M, Kam Y, Bolduan R, Amaral J, Hall T, Xu Z, Lee FT Jr, Ziemlewicz TJ. First-in-man histotripsy of hepatic tumors: the THERESA trial, a feasibility study. Int J Hyperthermia. 2022;39(1):1115-1123. doi: 10.1080/02656736.2022.2112309.