DefinePK

Description

Tripsy is a Greek Word. Tripsis means (friction, rubbing). It’s Suffix - Tripsy means crushing

We all are well aware of Lithotripsy. a treatment, typically using ultrasound shock waves, by which a kidney stone or other calculus is broken into small particles that can pbe passed out by the body.

Histotripsy - means Precise destruction of tissue by the non-thermal effects of focused ultrasound.

It consists of three steps:
Step No 1- High acoustic intensities with a short pulse duration generate small gas bubbles within the targeted tissue.
Step No 2- These bubbles collapse (Inertial cavitation)
Step No 3- a shockwave is generated which destroys cell membranes and even liquefies the cells of the region.

The focused ultrasound energy is delivered through the Edison System, manufactured and marketed by HistoSonics Inc, Plymouth, Minnesota. The system received FDA marketing approval on October 13, 2023.

This technique is very precise, causing minimal damage to surrounding tissue, and the bubbles used in cavitation are easily visible with ultrasound imaging, enabling accurate target verification and monitoring.

Clinically, histotripsy can be used for the treatment of cardiovascular diseases and various types of cancer, including liver, kidney, osteosarcoma, and soft tissue tumors.

A human trial is underway since 2021 at the Rogel Cancer Center and other locations has treated patients with primary and metastatic liver tumors via histotripsy, demonstrating the technology’s ability to meet the testing’s primary effectiveness and safety targets.

Just to summarize, Histotripsy works by using targeted ultrasound waves to form microbubbles within the tumor. The forces created as those bubbles form and collapse cause the mass to break apart, killing tumor cells and leaving the debris to be cleaned up by the immune system.

On the basis of two trials FDA gave approval to Histotripsy on 13th October 2023: Phase 1 THERESA Study and HOPE4LIVER trials.
* In the phase 1 THERESA study, in 8 patients with unresectable end-stage multifocal liver tumors, histotripsy met its primary endpoint of creating a zone of tissue destruction per planned volume assessed by MRI one day post-procedure. There were no device-related safety events.
* In the prospective HOPE4LIVER trials conducted in Europe and the US, the device has shown similar excellent results. The data was presented at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) meeting in September, which showed successful treatment of 42 of 44 tumors from the first 40 patients enrolled. The two tumors that were not successfully treated were missed because of user error, not device error.

In addition to liver tumors, the first approved indication, histotripsy is being explored for other solid tumors, such as cancers of the prostate, breast, kidneys, pancreas, and musculoskeletal system, including soft-tissue sarcomas. Studies are ongoing in both Europe and the United States

In its approval of the Edison System on Oct. 13, 2023, the FDA cautioned that “non-thermal focused ultrasound should only be considered in patients with a sufficient amount of functional liver reserve to withstand the destruction of the planned volume of liver tissue.”

So we hope that we shall be able to treat liver cancers (specially advanced stages) successfully with Histotripsy plus systemic therapy and we hope this technology becomes globally available including Pakistan in near future