Next-Generation Tumor Treatment: The Histotripsy Method

Histotripsy, as an emerging medical innovation, offers the potential to physically destroy tumors without surgery or radiation . This pioneering technology is attracting attention for its use of high-intensity focused ultrasound waves to create microscopic bubbles (microcavitation) in the target tissue. These bubbles collapse, mechanically breaking down tumor tissue.

Technology Recognized by the FDA and Authorized for Use

One histotripsy system, the Edison™ System (developed by HistoSonics), in October 2023 underwent FDA De Novo classification and received marketing authorization . This means the device can be used in the US market and that, rather than receiving a conventional “treatment approval,” it was deemed suitable for clinical use as a new, safe medical device . 

Clinical Research and Evidence

The efficacy and safety of histotripsy are being evaluated in the following clinical trials :

• HOPE4LIVER: The most important trial for liver tumors. The technical success rate is 95%, and the local tumor control rate is approximately 90% .
• HOPE4KIDNEY: Evaluates its use in renal (kidney) tumors. Patient recruitment is complete, and results are awaited.
• GANNON Study: A Barcelona-based pancreatic cancer trial. It is being tested in locally advanced, inoperable cases.
• CAIN Study: A United Kingdom-based, multicenter renal tumor clinical trial.

For Which Cancers Is It Used or Being Studied?

Current Uses (FDA Marketing Authorization and Clinical Practice)

• Liver Tumors: The most common application. It is used in both the US and the NHS (United Kingdom) for active patient treatment .

Areas in Clinical Trials

• Kidney Cancer: Being evaluated through the HOPE4KIDNEY and CAIN trials.
• Pancreatic Cancer: The GANNON trial is ongoing.
• Prostate, Breast, Musculoskeletal System, Brain: At the preclinical or early-phase experimental stage.

The Brain Cancer Example – A Realistic Comparison

Histotripsy is still experimental for brain tumors. Time and more data are needed before widespread use in this field. However, as an already proven, FDA-approved treatment for brain tumors, the Optune system (electric field therapy, TTFields) stands out. In glioblastoma and similar tumors, its efficacy has been demonstrated in randomized controlled trials.

For more detailed information about the Optune system, " title="click here" target="_blank" >tıklayınız.

In Which Countries Is It in Active Use?

• US: FDA marketing authorization is in place; used at centers such as Cleveland Clinic, Johns Hopkins, Hoag in clinical practice.
• United Kingdom (NHS): Cambridge, Leeds and Newcastle hospitals use it as an active treatment tool.
• Spain: The GANNON trial is being conducted in Barcelona at present.
• Netherlands: A histotripsy + immunotherapy combination trial has been planned.
• UAE, Hong Kong, Singapore: Trial applications are being carried out at selected centers.
• Türkiye: No clinical patient treatment yet. Some universities (İstanbul Medipol University) are conducting preclinical technical and laboratory studies.

Are Histotripsy and HIFU the Same?

No, histotripsy and HIFU (High Intensity Focused Ultrasound) are different technologies. HIFU uses focused ultrasound waves to cause thermal (heat) damage to tissue, destroying the tumor. Histotripsy produces entirely mechanical destruction ; it uses no heat. It therefore carries a lower risk of damage to surrounding tissues and provides sharper targeting.

For more information about HIFU (High Intensity Focused Ultrasound), click here.

Who Is It Suitable For, and Who Is It Not Suitable For?

Suitable For:

• Patients with localized, limited tumors in organs such as the liver or kidneys are candidates
• Patients unsuitable for surgery or at risk from surgery
• Patients who do not want radiotherapy or have received it previously
• Patients who meet clinical trial eligibility criteria

Not Suitable For:

• Patients whose tumors are very large, diffuse or very close to blood vessels are unsuitable
• Cases where reaching the target region with ultrasound is technically difficult
• Patients with active infection or a high risk of bleeding are in this group
• Patients seeking treatment at centers without appropriate histotripsy equipment

Advantages and Limitations

Advantages:

• No radiation → no risk of secondary tumors.
• No surgery required; noninvasive.
• Acts only on the target tissue while sparing healthy tissues.
• Can be performed in a single sessionwith a short recovery period.
• Preliminary evidence suggests it activates the immune system as well.

Limitations:

• Not suitable for every tumor type (deep or vascular areas)
• Very large tumors may require more than one session for treatment.
• Clinical data are still early; long-term effects are awaited.

Conclusion

Histotripsy is emerging as a revolutionary cancer treatment technology. Particularly in delicate, hard-to-access organs such as the liver , it offers treatment without surgery or radiation through targeted tumor destruction, a groundbreaking advance in medicine. However, this method is not yet suitable for every tumor type and every patient. Many applications also remain at the trial stage. The FDA’s marketing authorization and current clinical trials suggest that this technology may become much more widely used in the future. With today’s knowledge, however, histotripsy should be performed at safe centers with appropriate patient selection. Long-term data from follow-up will be decisive in integrating this method into healthcare systems.