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Ronny Allan
BREAKING NEWS 9TH OCT 2023 – US FDA APPROVES THE USE OF HISTOTRIPSY IN HUMANS FOR LIVER TREATMENT
….. and then read about Histotripsy and the clinical trials below
ORIGINAL ARTICLE FOLLOWS ……
A new technique that destroys cancer using soundwaves. It also spurs the immune system to kill off any of the tumour left behind, scientists have revealed. The non-invasive treatment only needs to be partially effective to stop the cancer spreading.
It is currently being tested on human liver cancers in the US and Europe following successful trials in rats. The team from the University of Michigan showed the non-invasive sound technology is able to prevent further spread with no evidence of recurrence or metastases in the majority of cases. The treatment, called histotripsy, noninvasively focuses ultrasound waves to mechanically destroy target tissue with millimetre precision. In many cases, the entirety of a cancerous tumour cannot be targeted directly in treatments due to the mass’ size, location or stage.
However, researchers investigated the effects of partially destroying tumours with sound to 50 or 75 per cent and found the technique was still very effective. They showed that in 80 per cent of cases performed on rats, the immune system broke down the rest of the tumour and it did not return.
Professor Zhen Xu, at the University of Michigan, said: “Even if we don’t target the entire tumour, we can still cause the tumour to regress and also reduce the risk of future metastasis. Our transducer delivers high amplitude microsecond-length ultrasound pulses—acoustic cavitation—to focus on the tumour specifically to break it up.
So, I guess you will now be thinking ….Does this work on Neuroendocrine Cancer liver metastases? The answer is that no one really knows as the human trials have only just begun. Edit: The clip from BBC below confirms a NET patient is on the trial.
Histotripsy is a type of ablation but uses a totally different technique which is non-invasive. It uses focused ultrasound waves to mechanically destroy target tissue with millimetre precision. In many cases, the entirety of a cancerous tumour cannot be targeted directly in treatments due to its size, location or stage.
Ablative techniques are currently used on Neuroendocrine Cancers so will this form of ablation work? Again, we simply don’t know for sure without clinical trials. This is hugely different tech. Radiofrequency ablation (RFA) and microwave ablation (MWA) use heat to destroy cancer cells or tumours (more than just the liver). The heat is supplied by electrical currents passed through a special needle placed directly into the liver. This may also be known as percutaneous ablation. Cryoablation for cancer is a treatment to kill cancer cells with extreme cold. During cryoablation, a thin, wand-like needle (cryoprobe) is inserted through your skin and directly into the cancerous tumour. All of these types are already used on Neuroendocrine Cancer but are invasive in nature. The success ratios and risks are known and documented.
Is this the same as High-Intensity Focused Ultrasound (HIFU)?
Not really but both may be in a grouping of similar treatments called “Focused Ultrasounds”. Histotripsy has some similarities with High-Intensity Focused Ultrasound (HIFU) but whereas HIFU employs thermal energy to ablate tissues, histotripsy harnesses the energy of thousands of microbubbles — called cavitation — to emulsify tissue.
HIFU is not known as a regular treatment for Neuroendocrine Cancer but is frequently used in (e.g.) Prostate and Uterine Fibroids. I can also see its deployment in cosmetic surgery. HIFU is limited by long treatment times and the requirement for MRI thermometry or quantitative B-mode imaging for real-time feedback of treatment. Furthermore, thermal ablation of highly perfused tissue can be imprecise, inconsistent, or ineffective.
As far as I am aware, neither HIFU nor Histotripsy has been trialed in Neuroendocrine Cancer patients, nor have they been approved for use in the treatment of Neuroendocrine Cancers. Edit: The clip from BBC below confirms a NET patient is on the trial.
Human Clinical Trials of Histotripsy
There are trials in Europe and US.
US Trial – (8 sites in 6 states) – The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy – Full Text View – ClinicalTrials.gov
Clearly given the US announcement above, this clinical trial may be deemed complete
Europe Trial – (6 sites in 4 countries) The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy (#HOPE4LIVER) – Full Text View – ClinicalTrials.gov
Two of the sites are in UK. So far, two patients have been treated with histotripsy in Leeds and two at the Freeman Hospital in Newcastle. Cancer types of patients not known.
FDA authorization mentioned above against the US trial was based, in part, on data from the #HOPE4LIVER Trials in 13 trial sites across the US and Europe. Data pooled from both the US and European/UK trials were used to assess the clinical safety and efficacy of histotripsy in destroying targeted primary and secondary liver tumors. It follows that this clinical trial may also be complete and European approval may follow soon.
Histotripsy Research and innovation news (leedsth.nhs.uk)
In a real-world example of the utility of Histotripsy beyond liver metastases/tumours, this article from 2023 where a UK NHS Hospital performed a world first Non-Invasive Histotripsy in Patient with Primary Solid Renal Tumor. This indicates the possibilities of employment against primary tumours outside the liver.
This marked the initial treatment in the Histosonics sponsored “CAIN” Trial where Anthony Harris aged 73 from Castleford was the first patient in the world to receive this novel approach to treatment of a kidney tumour.
Read more by clicking here.
The Cain Trial is a small trial of 20 participants based on Renal/Kidney tumours. Read more here.
Summary
The only thing I am sure about is that I will be keeping an eye on the development of Histotripsy and bringing you news directly via all my sites and accounts. Stay tuned.
As I keep telling you, we should always hope for breakthroughs, but it’s very early days for Neuroendocrine Cancer.
For the hope angle, read the story of 68-year-old Sheila Riley from UK – click here
Featured on BBC TV Show “Click” (including a NET Patient)
Featured on BBC TV Show “Click” on 12 Nov but now available on YouTube by clicking here or on the picture below. This may not be available in your country.
Summary
The only thing I am sure about is that I will be keeping an eye on the development of Histotripsy and bringing you news directly via all my sites and accounts. Stay tuned.
As I keep telling you, we should always hope for breakthroughs, but it’s very early days for Neuroendocrine Cancer.
For the hope angle, read the story of 68-year-old Sheila Riley from UK – click here
Sources used in compiling this article
- Tumors partially destroyed with sound don’t come back | University of Michigan News (umich.edu) (2022)
- New Ultrasonic Therapy Obliterates Tissue Without Physical Contact | University of Michigan (uofmhealth.org) (2016 article)
- For Whom the Bubble Grows: Physical Principles of Bubble Nucleation and Dynamics in Histotripsy Ultrasound Therapy – ScienceDirect (2019)
- Radical new therapy uses tiny bubbles of gas to destroy tumours | Daily Mail Online
- Research and innovation news (leedsth.nhs.uk)
- Tumor-destroying sound waves receive FDA approval for liver treatment in humans | University of Michigan News (umich.edu)
Disclaimer
I am not a doctor or any form of medical professional, practitioner or counsellor. None of the information on my website, or linked to my website(s), or conveyed by me on any social media or presentation, should be interpreted as medical advice given or advised by me.
Neither should any post or comment made by a follower or member of my private group be assumed to be medical advice, even if that person is a healthcare professional.
Please also note that mention of a clinical service, trial/study or therapy does not constitute an endorsement of that service, trial/study or therapy by Ronny Allan, the information is provided for education and awareness purposes and/or related to Ronny Allan’s own patient experience. This element of the disclaimer includes any complementary medicine, non-prescription over the counter drugs and supplements such as vitamins and minerals.
Finally
Whenever I post about a trial or study, some people get excited without understanding that these new treatments and capabilities can very often take years to come to fruition and it’s also possible that clinical trials can be halted, or that national approval agencies will not approve the final product. Plus, not everyone will be eligible, so always check the exclusion and inclusion criteria in the relevant clinical trials document. Please bear that in mind when reading studies/clinical trials posted on RonnyAllan.NET
General Clinical Trials Disclaimer
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided in the clinical trials document. It’s very important to check the trial inclusion and exclusion criteria before making any contact. If you need questions, the articles here is very useful Questions to Ask About Clinical Trials | Cancer.Net
The inclusion of any trial within this blog should not be taken as a recommendation by Ronny Allan.
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Hi Ronnie
This treatment has been around for years, there are many treatments out there that big pharma don.t want you to know about people were at the time shut up about it if you get my meaning, Mmmm strange how it is coming to light all of a sudden, Oh and I have Neuroendocrines Tumours in my Lymph nodes after having most of my Pancreas and tumour taken away 2011.
Key difference now is human trials, so it’s worth a post.