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

• Sponsor: HistoSonics, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05432232
• Collaborator: (none)
• Enrollment: 20
• Arm: 1
• Anticipated Duration (Months): 12

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: This trial is prospective, multi-center, single-arm.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
• Anticipated Study Start Date: Aug 31, 2022
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Aug 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Primary Effectiveness Endpoint [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. Calculated creatinine clearance ≤14 days prior to the planned index procedure date ≥45mL/min using the Cockcroft-Gault formula

2. 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

1. The tumor selected for histotripsy treatment must be ≤3cm in longest diameter

2. Subject has an adequate acoustic window to visualize targeted tumor using the histotripsy system

3. 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

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 six (< 6) months

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

1. The targeted tumor is not clearly visible with diagnostic ultrasound and either magnetic resonance imaging (MRI) or computerized tomography (CT)

2. Targeted tumor with adequate margin does not overlap the renal pelvis, main renal vessel, ureter, or other vital structure

3. Targeted tumor with adequate margin does not overlap a non-targeted tumor visible via imaging

4. The treatment of the tumor will not allow for an adequate margin as determined by the investigator -

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• HistoSonics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: HistoSonics, Inc.
• ClinicalTrials.gov Identifier: NCT05432232
• Other Study ID Numbers: CSP2276
• First Posted: Jun 27, 2022
• Last Update Posted: Jul 27, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Neoplasms; Kidney Neoplasms

Study Results

No Results Posted as of Jul 27, 2022