Histotripsy for Kidney Cancer

(#HOPE4KIDNEY Trial)

Not currently recruiting at 14 trial locations

Overseen By Zoe Secord

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HistoSonics, Inc.

Must not be taking: Aspirin, NSAIDS, Anticoagulants

Disqualifiers: Pregnancy, Active cancers, Dialysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 195

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the HistoSonics Edison System to evaluate its safety and effectiveness in destroying kidney tumors. The focus is on individuals with a single, small kidney tumor that hasn't spread. The trial seeks participants diagnosed with a solid kidney tumor measuring 3cm or smaller, confirmed by biopsy. Candidates with a single kidney tumor who can undergo general anesthesia may be suitable for this trial.

As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research and potentially benefit from an innovative treatment.

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications, but you must not take Aspirin or NSAIDs within 7 days before the procedure. It's best to discuss your specific medications with the trial team.

What prior data suggests that the HistoSonics Edison System is safe for treating kidney cancer?

Research has shown that the HistoSonics Edison System, currently tested for kidney tumors, has been safe in other applications. The FDA has approved the system for liver tumors, indicating it is generally well-tolerated. In studies involving liver tumors, participants achieved a high rate of local tumor control, and no major side effects occurred.

Although the Edison System is not yet approved for kidney tumors, its success in liver treatments suggests it might be safe. The treatment is non-invasive, meaning it doesn't involve surgery or cuts, which usually results in fewer side effects. This background provides some confidence in its potential safety for kidney tumor treatment, but specific results for kidney use are still under study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The HistoSonics Edison System is unique because it uses histotripsy, a non-invasive ultrasound technology, to target and destroy kidney cancer cells without the need for surgery or radiation. Unlike current treatments like surgery, chemotherapy, or radiation therapy, which can be invasive or have significant side effects, histotripsy precisely focuses sound waves to mechanically disrupt tumor tissues, potentially leading to fewer side effects and quicker recovery times. Researchers are excited about this technology because it offers a novel, less invasive approach that could significantly improve patient outcomes and quality of life.

What evidence suggests that the HistoSonics Edison System is effective for kidney cancer?

Research has shown that histotripsy, the technology used in the HistoSonics Edison System, may effectively treat tumors in various organs, including the kidney. This trial will evaluate the HistoSonics Edison System, which uses sound waves to break down tumors without surgery or needles. Early reports emphasize its non-invasive nature and its ability to specifically target kidney tumors. Patients with small, localized kidney tumors have participated in studies to test this method. Initial findings suggest histotripsy could safely and effectively destroy targeted kidney tumors. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults over 22 with a single, non-metastatic kidney tumor no larger than 3cm, confirmed by CT or MRI. Participants must be able to undergo general anesthesia and have certain blood count levels within normal ranges. They should not have had previous treatments on the tumor, be pregnant, or have specific genetic predispositions to kidney cancer.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

My tumor is 3cm or smaller in size.

My tumor can be seen clearly with ultrasound for treatment.

Exclusion Criteria

My treatment won't fully remove the cancer with safe margins.

My tumor was treated with targeted local therapy like radiation.

The doctors cannot clearly see the tumor with ultrasound, MRI, or CT scans.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a single histotripsy session using the HistoSonics Edison System for the destruction of kidney tissue

1 day

1 visit (in-person)

Primary Analysis

Data through 90 days for all enrolled subjects will be summarized for Regulatory Submission to the FDA

90 days

Evaluations at 14-day, 30-day, and 90-day time points

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Evaluations at 180-day and annual time points

What Are the Treatments Tested in This Trial?

Interventions

• HistoSonics Edison System

Trial Overview The HistoSonics Edison System is being tested for its ability to safely destroy primary solid renal tumors using histotripsy—a non-invasive technique that uses ultrasound energy.

How Is the Trial Designed?

Group I: HistoSonics Edison System Experimental Treatment 1 Intervention

HistoSonics Edison System is already approved in United States for the following indications:

Approved in United States as Edison System for:

• Liver tumors

Who Is Running the Clinical Trial?

HistoSonics, Inc.

Lead Sponsor

Trials

9

Recruited

5,200+

Published Research Related to This Trial

Immunotherapy using tumor-infiltrating lymphocytes (TIL) shows promise as a new treatment for kidney cancer metastases, which are difficult to treat with traditional methods like surgery and chemotherapy.

In early clinical trials, activated lymphocytes, cultivated with Interleukin 2 to enhance their cancer-fighting abilities, have demonstrated encouraging results, indicating a potential breakthrough in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A new therapeutic concept in the treatment of metastatic cancers of the kidney: the TIL (tumor infiltrating lymphocytes)]. Peyret, C.[2006]

Allogeneic anti-CD3 antibody induced activated killer (CD3AK) cells demonstrated a significant inhibitory effect on the growth of human renal cell cancer (RCC) in SCID mice, leading to reduced tumor weight and slower tumor growth compared to control groups.

The study showed that CD3AK cells not only exerted a lethal effect on the OS-RC-2 renal cancer cell line but also enhanced the immune response in the mice, indicating their potential as a therapeutic option for RCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of allogeneic CD3AK cells on transplanted human renal cell cancer in mice with severe combined immune deficiency. Ge, L., Shan, Z., Han, Q., et al.[2017]

An integrated therapy combining Vinblastine and alfa-2A-IFN was tested on 12 patients with metastatic renal carcinoma to reduce metastasis that couldn't be surgically removed and to limit micrometastatic spread.

The study suggests that this combined treatment may play a beneficial role following surgery, although further conclusions should be drawn cautiously.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adjuvant therapy with vinblastine and interferon in metastatic renal carcinoma]. Cocimano, V., Marino, G., Brigato, R., et al.[2018]

Combining anti-CD3 monoclonal antibodies with IL-2 significantly improves treatment outcomes in a murine model of renal cell cancer, leading to fewer pulmonary metastases and longer survival compared to either treatment alone.

This combination therapy enhances the expression of key molecules involved in the immune response, such as perforin and granzyme B, suggesting a stronger cytotoxic attack against tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunostimulatory therapy with anti-CD3 monoclonal antibodies and recombinant interleukin-2: heightened in vivo expression of mRNA encoding cytotoxic attack molecules and immunoregulatory cytokines and regression of murine renal cell carcinoma. Asano, T., Khanna, A., Lagman, M., et al.[2019]

Checkpoint inhibitors (CPI) have transformed the first-line treatment for metastatic renal cell carcinoma, showing effectiveness and safety when combined with tyrosine kinase inhibitors (TKI).

Currently, up to five different combination treatments are available based on individual patient risk profiles, emphasizing the need for personalized treatment plans and interdisciplinary discussions for complex cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[First-line treatment of metastatic renal cell carcinoma]. Bruchbacher, A., Netsch, C., Gross, AJ.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05820087

Study Details | NCT05820087 | The HistoSonics Edison™ ... The purpose of this trial is to evaluate the effectiveness and safety of the HistoSonics Edison System for the destruction of kidney tissue by treating primary ...

2. evtoday.com evtoday.com/news/histosonics-edison-system-to-treat-kidney-tumors-completes-pivotal-trial-enrollment

HistoSonics Edison System to Treat Kidney Tumors ... HistoSonics reported that the trial enrolled patients with a single, nonmetastatic solid kidney mass ≤ 3 cm, confirmed by imaging and biopsy.

3. histosonics.com histosonics.com/news/worlds-first-kidney-tumor-treated-using-the-histosonics-edison-histotripsy-system/

World's First Kidney Tumor Treated Using the HistoSonics ... The company's breakthrough Edison System to destroy targeted kidney tumors, completely non-invasively and without the need for needles or incisions.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12469116/

Histotripsy: Recent Advances, Clinical Applications, and ... Histotripsy has shown strong potential in the treatment of tumors involving the liver, pancreas, kidney, brain, and cardiovascular system. It ...

5. urologytimes.com urologytimes.com/view/pivotal-trial-of-histotripsy-system-for-kidney-tumors-reaches-enrollment-goal

Pivotal trial of histotripsy system for kidney tumors reaches ... Data from the #HOPE4KIDNEY trial is intended to support submission for regulatory clearance of the Edison Histotripsy System.

6. fusfoundation.org fusfoundation.org/posts/histotripsy-for-liver-tumors-one-year-data-suggest-90-tumor-control/

Histotripsy for Liver Tumors: One-Year Data Suggest 90% ... Researchers found that after 12-months, participants experienced a 90% local tumor control rate across all treated tumors regardless of tumor type or origin.