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The HistoSonics Investigational System for Treatment of Primary Solid Renal Tumors Using Histotripsy (CAIN)

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ClinicalTrials.gov Identifier: NCT05432232
Recruitment Status : Recruiting
First Posted : June 27, 2022
Last Update Posted : March 21, 2024
Sponsor:
Information provided by (Responsible Party):
HistoSonics, Inc.

Study Description
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Brief Summary:
The purpose of this trial is to evaluate the technical success and safety profile of the HistoSonics Investigational System for the treatment of primary solid renal tumors.

Condition or disease Intervention/treatment Phase
Renal Cancer Tumor, Solid Kidney Cancer Tumor Tumor, Benign Kidney Neoplasms Device: HistoSonics Investigational System Not Applicable

Detailed Description:
This trial is a prospective, multi-center, single-arm pilot trial designed to evaluate the effectiveness and safety profile of the HistoSonics Investigational System in treating primary solid renal tumors. Following histotripsy treatment of the solid renal tumor, subjects will undergo imaging ≤36 hours post-index procedure to determine technical success. Additionally, subjects will be followed 180 days (6 months) post-index procedure, with evaluations at the 14-day, 30-day, 90-day, and 180-day time points to establish the efficacy and safety profile of the HistoSonics Investigational System.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a prospective, multi-center, single-arm, pilot trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The HistoSonics Investigational System for Treatment of Primary Solid Renal Tumors Using Histotripsy
Actual Study Start Date : March 23, 2023
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: HistoSonics Investigational System Device: HistoSonics Investigational System
The HistoSonics Investigational System is intended for the non-invasive destruction of kidney tissue using histotripsy, a non-thermal mechanical process of focused ultrasound.
Other Name: Histotripsy


Outcome Measures
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Primary Outcome Measures :
  1. Primary Effectiveness: Technical Success [ Time Frame: Up to 36 hours after the index procedure ]
    Technical success, defined as complete coverage of the tumor as determined ≤36 hours post-index procedure by magnetic resonance imaging (MRI) or computerized tomography (CT). [Core Lab Adjudicated]

  2. Primary Safety: Freedom from Index Procedure Related Major Complications [ Time Frame: 30 days Post-Index Procedure ]
    Freedom from index procedure related major complications, defined by Clavien-Dindo Classification Grade 3 or higher up to 30 days after the last histotripsy procedure. [Clinical Events Committee Adjudicated]


Eligibility Criteria
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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) 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 a non-metastatic solid renal mass ≤3cm confirmed via CT or MRI ≤ 30 days prior to the index procedure date.
  4. Subject can tolerate general anesthesia.
  5. Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade 0-2 at baseline screening.

  6. Subject meets all the following functional criteria at ≤14 days prior to the planned index procedure date:

    • White Blood Cell (WBC) ≥3,000/mm3
    • Absolute Neutrophil Count (ANC) ≥1,200/mm3
    • Hemoglobin (Hgb) ≥9 g/dL
    • Platelet count ≥100,000/mm3 (≥100 10*9/L)
    • White Blood Cell (WBC) ≤40 cells/µL via urinalysis
    • Albumin ≤300,000 mg/L via urinalysis
  7. Subject has an eGFR ≥45mL/min, ≤14 days prior to the planned index procedure date.

  8. International Normalized Ratio (INR) score of <1.5:

    • If on anticoagulants, other than aspirin or non-steroidal anti-inflammatory drugs, assessment must be performed on the day of the procedure; OR
    • If only on aspirin or non-steroidal anti-inflammatory drugs, assessment must be performed ≤14 days prior to the planned index procedure date; OR
    • If not on anticoagulants, assessment must be performed ≤14 days prior to the planned index procedure date
  9. Biopsy is required to determine the type of tumor and must be performed ≥14 days prior to the planned index procedure date.
  10. The tumor selected for histotripsy treatment must be ≤3cm in longest diameter.
  11. Subject has an adequate acoustic window to visualize targeted tumor using the HistoSonics Investigational System.
  12. Subject will undergo histotripsy treatment of only one (1) tumor 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 and being actively treated in another investigational pharmaceutical or device trial ≤30 days prior to planned index procedure date.
  3. Subject is undergoing active chemotherapy for any cancer ≤14 days prior to planned index procedure date.
  4. Subject is undergoing active immunotherapy ≤40 days prior to planned index procedure date.
  5. 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 Investigational System.
  6. Subject is on dialysis or being considered for dialysis.
  7. Subject has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or better from any adverse effects (except alopecia and neuropathy) related to previous anti-cancer therapy.
  8. Subject has an uncorrectable coagulopathy other than that induced by aspirin or non-steroidal anti-inflammatory drugs.
  9. Subject has a planned cancer treatment (e.g., nephrectomy, chemotherapy, immunotherapy etc.) prior to completion of the 30-day follow-up visit.
  10. Subject has had previous treatments with chemotherapy, radiotherapy, or both that have not been discontinued ≥14 days prior to the planned index procedure date and have not recovered (CTCAE grade 2 or better) from related toxicity (exclusive of alopecia and neuropathy).
  11. Subject has previous treatment with immunotherapies that has not been discontinued ≥40-days prior to the planned index procedure date and has not recovered from related toxicity (CTCAE grade 2 or better).
  12. Subject has a life expectancy less than one (< 1) year.
  13. In the investigator's opinion, histotripsy is not a treatment option for the subject.
  14. Subject has a concurrent condition that could jeopardize the safety of the subject or compliance with the protocol.
  15. Subjects' targeted tumor has had prior locoregional therapy (e.g., ablation, embolization, radiation).
  16. Subjects' tumor is not treatable by the HistoSonics Investigational System's working ranges (refer to User Guide).
  17. In the physician's opinion, the anticipated risk of intervention outweighs the potential benefits of the intervention.
  18. Subject has acute renal failure.

  19. Subject has a genetic predisposition to kidney cancer such as:

    • Von Hippel Lindau (VHL)
    • Hereditary Papillary Renal Carcinoma (HPRC)
    • Birt-Hogg-Dubé Syndrome (BHD)
    • Tuberous Sclerosis Complex (TSC)
    • Hereditary Leiomyomata's Renal Cell Carcinoma (HLRCC)
    • Reed's Syndrome
    • Succinate Dehydrogenase B Deficiency (SDHB)
    • BRCA 1 associated protein -1 (BAP1) Renal Cell Carcinoma
    • MITF predisposed Renal Cell Carcinoma
  20. Tumor is an angiomyolipoma.
  21. Subject has a known sensitivity to contrast media and cannot be adequately pre-medicated.
  22. The targeted tumor is not clearly visible with diagnostic ultrasound and either magnetic resonance imaging (MRI) or computerized tomography (CT).
  23. Targeted tumor with adequate margin overlaps the renal pelvis, main renal vessel, ureter, or other vital structure.
  24. Targeted tumor with adequate margin overlaps a non-targeted tumor visible via imaging.
  25. The treatment of the tumor will not allow for an adequate margin as determined by the investigator.
Contacts and Locations
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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): NCT05432232


Contacts
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Contact: Amber Dickson 612-351-0361 amber.dickson@histosonics.com
Contact: Zoe Secord 612-351-0361 zoe.secord@histosonics.com

Locations
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United Kingdom
Leeds Teaching Hospitals NHS Trust Recruiting
Leeds, United Kingdom, LS9 7TF
Contact: Jakki Brandon       j.brandon@nhs.net   
Principal Investigator: Tze Wah, MD         
Sponsors and Collaborators
HistoSonics, Inc.
More Information
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Responsible Party: HistoSonics, Inc.
ClinicalTrials.gov Identifier: NCT05432232    
Other Study ID Numbers: CSP2276
First Posted: June 27, 2022    Key Record Dates
Last Update Posted: March 21, 2024
Last Verified: March 2024
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
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases