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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05432232
Recruitment Status : Recruiting
First Posted : June 27, 2022
Last Update Posted : April 5, 2023
Sponsor:
Information provided by (Responsible Party):
HistoSonics, Inc.

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

Condition or disease Intervention/treatment Phase
Renal Cancer Tumor, Solid Kidney Cancer Tumor Tumor, Benign Device: HistoSonics 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 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 System.

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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 trial is prospective, multi-center, single-arm.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The HistoSonics System for Treatment of Primary Solid Renal Tumors Using Histotripsy
Actual Study Start Date : March 23, 2023
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

Arm Intervention/treatment
Experimental: Histotripsy
HistoSonics System: non-invasive destruction of kidney tissue using histotripsy
Device: HistoSonics System
HistoSonics System: non-invasive destruction of kidney tissue using histotripsy, a non-thermal mechanical process of focused ultrasound.




Primary Outcome Measures :
  1. Primary Effectiveness Endpoint [ 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).

  2. Primary Safety Endpoint [ 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.



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) 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
    • White Blood Count (WBC) ≤5 hpf via urinalysis
    • Albumin ≤300 mg/g 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 histotripsy 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 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/have had prior locoregional therapy (e.g., ablation, embolization, radiation).
  16. Subjects' tumor is not treatable by the System's working ranges (refer to User Manual).
  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.

    -


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: Daffodil Pastor       daffodil.pastor@nhs.net   
Principal Investigator: Tze Wah, MD         
Sponsors and Collaborators
HistoSonics, Inc.
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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: April 5, 2023
Last Verified: April 2023
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