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The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy (#HOPE4LIVER US)

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ClinicalTrials.gov Identifier: NCT04572633
Recruitment Status : Recruiting
First Posted : October 1, 2020
Last Update Posted : November 2, 2021
Sponsor:
Information provided by (Responsible Party):
HistoSonics, Inc.

Brief Summary:
This trial is a single arm, non-randomized prospective trial. The objective of this trial is to evaluate the efficacy and safety of the HistoSonics System for the treatment of primary or metastatic tumors located in the liver.

Condition or disease Intervention/treatment Phase
Liver Tumor HCC Metastasis Device: HistoSonics Histotripsy Not Applicable

Detailed Description:
This trial is a single arm, non-randomized prospective trial. Following histotripsy treatment of liver tumor(s), subjects will undergo imaging ≤36 hours post-index procedure to determine technical success. Subjects will then be followed for 30 days. Data through the 30-day time point will be used for a Regulatory Submission to the FDA. Additionally, subjects will be followed for five (5) years post-index procedure, with evaluations at the 6-month and annual time points to estimate the efficacy and safety profile of the HistoSonics System.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This trial is a single arm, non-randomized prospective trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy (#HOPE4LIVER US)
Actual Study Start Date : January 27, 2021
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : July 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arm Intervention/treatment
Experimental: Treatment Group
This is a single are arm study that intends to treat all enrolled subjects with the histotripsy device.
Device: HistoSonics Histotripsy
The HistoSonics System (System) is intended for the destruction of liver tissue using histotripsy, a non-thermal, mechanical process using focused ultrasound.




Primary Outcome Measures :
  1. Technical success as determined, at ≤36 hours post-index procedure, by evaluating the histotripsy treatment size and coverage. [ Time Frame: ≤36 hours post-index procedure ]
    Technical Efficacy

  2. Index procedure related major complications defined as Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher toxicities, up to 30 days post index-procedure. [ Time Frame: 30 days post-index procedure ]
    Safey


Secondary Outcome Measures :
  1. Lack of a nodular or mass-like areas of enhancement within or along the edge of the treatment volume [ Time Frame: 30 days post-index procedure ]
    Technique Efficacy

  2. All adverse events reported within 30 days of the index procedure. [ Time Frame: 30 days post-index procedure ]
    Safety



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is ≥18 years of age
  2. Subject has signed the Ethics Committee (EC) or Institutional Review Board (IRB) approved trial Informed Consent Form (ICF) prior to any trial related tests/procedures and is willing to comply with trial procedures and required follow-up assessments
  3. Subject is diagnosed with hepatocellular carcinoma (HCC) or liver metastases (mets) from other primary cancers
  4. Subject is able to undergo general anesthesia
  5. Subject has a Child-Pugh Score of A or B
  6. Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade 0-2 at baseline screening
  7. Subject meets the following functional criteria, ≤7 days prior to the index-procedure:

    • Liver function: Alanine transaminase (ALT) and Aspartate transaminase (AST) <2.5x upper limit of normal (ULN) and/or bilirubin <2.5 ULN, and
    • Renal function: serum creatinine <2x ULN, and
    • Hematologic function: neutrophil count >1.0 x 10^9/L and platelet >50 x 10^9/L
  8. Subject has an International Normalized Ratio (INR) score of <2.0 , ≤7 days prior to the index procedure
  9. Subject has not responded to and/or has relapsed and/or is intolerant of other available therapies including locoregional therapies, chemotherapy, immunotherapy and targeted therapies
  10. The tumor(s) selected for histotripsy treatment must be ≤3 cm in longest diameter
  11. Subject has an adequate acoustic window to visualize targeted tumor(s) using ultrasound imaging
  12. Subject has a maximum of three (3) tumors to be treated with histotripsy during the index procedure, regardless of how many tumors the subject has.

Exclusion Criteria:

  1. Subject is pregnant or planning to become pregnant or nursing (lactating) during the trial period
  2. Subject is enrolled in another investigational trial and/or is taking investigational medication and/or has been treated with an investigational device ≤30-days prior to planned index procedure date
  3. In the Investigator's opinion, the subject has co-morbid disease(s) or condition(s) that would cause undue risk and preclude safe use of the HistoSonics System
  4. Subject has a serum creatinine >2.0 mg/dL or estimated glomerular filtration rate (EGFR) <30, unless on dialysis
  5. Subject has major surgical procedure or significant traumatic injury ≤2 weeks prior to the planned index procedure or not fully recovered (CTCAE grade 1 or better) from side effects/complications of such procedure or trauma
  6. Subject has not recovered to common terminology criteria for adverse events (CTCAE) grade 1 or better from any adverse effects (except alopecia, fatigue, nausea, vomiting and peripheral neuropathy) related to previous anti-cancer therapy
  7. Subject has a history of, or suspected to have, bleeding disorders that are uncorrectable
  8. Subject has coagulopathy that is uncorrectable
  9. Subject has a planned cancer treatment (e.g. resection, chemotherapy, etc.) after the planned index-procedure date and prior to completion of the 30-day follow-up visit
  10. Subject has previous treatment with bevacizumab that has not been discontinued >40 days prior to the planned index-procedure date
  11. Subject has planned bevacizumab treatment prior to completion of the 30-day follow-up visit
  12. Subject has previous treatments with chemotherapy and/or radiotherapy that has not been discontinued ≥2 weeks prior to the planned index-procedure date and has not recovered (CTCAE grade 1 or better) from related toxicity (except alopecia and peripheral neuropathy)
  13. Subject has previous treatment with immunotherapies that has not been discontinued ≥4 weeks prior to the index-procedure and has not recovered from related toxicity (CTCAE grade 1 or better)
  14. Subject has a life expectancy less than six (<6) months
  15. In the opinion of the Investigator, histotripsy is not a treatment option for the subject
  16. Subject has a concurrent condition that, in the investigator's opinion, could jeopardize the safety of the subject or compliance with the protocol
  17. Subjects' tumor(s) is not treatable by the System's working ranges (refer to User Manual)
  18. Subject has a known sensitivity to contrast media and cannot be adequately pre-medicated
  19. Subjects' target tumor(s) has/have had prior locoregional therapy (e.g. ablation, embolization, radiation)
  20. Subject is eligible for surgical resection
  21. Targeted tumor(s) treatment volume overlaps a non-targeted tumor visible via imaging
  22. The targeted tumor(s) is not clearly visible with diagnostic ultrasound and computed tomography (CT) or magnetic resonance (MR) imaging
  23. The targeted tumor(s) is located in liver segment 1
  24. The Planned Treatment Volume intended to cover the targeted tumor includes or encompasses any portion of the main portal vein, common hepatic duct, common bile duct, gallbladder or stomach/bowel.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04572633


Contacts
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Contact: Zoe Secord 763-300-7313 zoe.secord@histosonics.com
Contact: Christine Sullivan 651-398-7586 christine.sullivan@histosonics.com

Locations
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United States, Florida
Miami Cancer Institute Recruiting
Miami, Florida, United States, 33176
Contact: Ivette Cruz       ivettec@BaptistHealth.net   
Principal Investigator: Govindarajan Narayanan, MD         
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Ashley Bader       abader@tgh.org   
Contact: Patricia Sanchez       psanchez@tgh.org   
Principal Investigator: Clifford Davis, MD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Pamela Lofton, RN       plofton@radiology.bsd.uchicago.edu   
Principal Investigator: Osmanuddin Ahmed, MD         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Peyton Ackerman       packerman@kumc.edu   
Principal Investigator: Zach Collins, MD         
United States, Michigan
University of Michigan Hospital Recruiting
Ann Arbor, Michigan, United States, 48109-5030
Contact: Valerie Khaykin       vkh@med.umich.edu   
Principal Investigator: Mishal Mendiratta-Lala, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Eric Homan       homa0030@umn.edu   
Principal Investigator: Shamar Young, MD         
United States, Wisconsin
University Hospital - UW Health Recruiting
Madison, Wisconsin, United States, 53792-3252
Contact: Janice Yakey       jyakey@uwhealth.org   
Principal Investigator: Lori Mankowski Gettle, MD         
Medical College of Wisconsin/Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Barbara Dion       badion@mcw.edu   
Principal Investigator: Sarah White, MD         
Sponsors and Collaborators
HistoSonics, Inc.
Investigators
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Principal Investigator: Timothy J Ziemlewicz, MD University of Wisconsin, Madison
Principal Investigator: Clifford S Cho, MD University of Michigan
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Responsible Party: HistoSonics, Inc.
ClinicalTrials.gov Identifier: NCT04572633    
Other Study ID Numbers: CSP1427
First Posted: October 1, 2020    Key Record Dates
Last Update Posted: November 2, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by HistoSonics, Inc.:
metastasis
HCC
liver
tumor
histotripsy
hepatocellular Carcinoma
Liver Cancer
Liver cell carcinoma
metastatic
ablation
nodule
nodular
cancer treatment
locoregional therapy
chemotherapy
immunotherapy
resection
radiotherapy
Additional relevant MeSH terms:
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Neoplasm Metastasis
Liver Neoplasms
Neoplasms
Neoplastic Processes
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases