First published on
If you just want to know what Histotripsy is, just head straight down to “Original Article” section
19th September 2025. Australia
Cholangiocarcinoma Foundation Australia have taken the lead and are campaigning for access to this innovative treatment. As NET patients in Australia, you can help.
Read more by clicking here
April 2025. Singapore
Singapore’s National Cancer Centre Singapore (NCCS)Search company and National University Cancer Institute, Singapore (NCIS). Company are set to begin clinical trials of a revolutionary cancer disease treatment called histotripsy in the second half of 2025. This ground-breaking technology uses precisely targeted ultrasound waves to generate microbubbles that destroy tumor cells without incisions, radiation, or damage to surrounding tissues.
The S$12 million initiative is funded by the Li Ka Shing Foundation company and Temasek Trust company, which will provide two histotripsy drug machines—the first such devices in Southeast Asia. One machine will be placed at NCCS and the other at NCIS.
Read more by clicking here
13th March 2025. Ronny launches Histotripsy blog for UK
Read more by clicking here or on the graphic below.
18th February 2025 – A summary paper on Histotripsy treatments to date. 2nd largest cohort is NET!
I picked up this draft (not yet peer reviewed) paper which is of interest. One of the striking statistics is the inclusion of NET patients with liver metastases indicating that we are definitely a target for treatment. NETs comprised 16% of all patients receiving the treatment. The number of liver tumours treated was from 1 to 3. Prior to this study only 53 cases of histotripsy on human patients had been reported, all in a trial setting. This study represents a 600% increase in Histotripsy treatment on human patients.
Research in Context
Evidence Before this Study: Prior to this study, there are only 53 cases of histotripsy on human patients have been reported, all in a trial setting, generally supporting the safety of this technology.
Added Value: Twelve of 230 patients (5.1%) experienced any complication. Most were minor (n=9, 75%, Clavien-Dindo Grade II). Median and mean CCI were 0 (IQR 0-0) and 0 points (95%CI 0-0.75). All three major complications were death from disease progression in patients with known advanced malignancy (> Clavien-Dindo Grade II, 1.3%).
Implications of all the available evidence: This international report demonstrates few
complications within 30 days of histotripsy, and major complications were rare. This complication profile compares favourably to other liver-directed and surgical options for treatment of liver tumors. Collectively with trial cases, this supports the safety of this relatively radical technological shift in treatment for liver tumors.
Study Abstract
Background: Histotripsy is a novel, non-invasive, non-ionizing, non-thermal approach using focused ultrasound waves to treat liver tumors. The technology received FDA De Novo grant in late 2023. This is the first reporting of post-trial, real-world clinical outcomes. We aim to report short-term safety data from most centers performing histotripsy internationally.
Methods: Safety outcomes within 30 days of histotripsy were collected since FDA clearance (12/22/2023 – 7/25/2024). All centers who have performed histotripsy were invited to participate. Complications requiring treatment were graded using Clavien-Dindo and Comprehensive Complications Index (CCI).
Results: In total, 295 patients received histotripsy to 510 tumors at 18 centers. Treated liver tumor types included colorectal metastases (n=140), neuroendocrine (n=46), hepatocellular carcinoma (n=31), pancreas (n=30), and breast metastases (n=26). The most common number of tumors treated per procedure were 1 (n=170), 2 (n=69), and 3 (n=37). Tumors were treated in all 8 liver segments. Safety data was available for 230 patients from 9 centers. A total of 12 out of 230 patients experienced complications of any grade (5.2%). Most (n=9, 75%) were minor (< Clavien-Dindo Grade II). Median and mean CCI were 0 (IQR 0-0) and 0 points (95%CI 0-0.75). All three major
complications (>Clavien-Dindo grade II, 1.3%) were death from disease progression. All three of these patients had undergone histotripsy with palliative intent for known advanced intra- and extrahepatic disease.
Interpretation: This is the first report on the real-world therapeutic use of histotripsy for liver tumors. Histotripsy was well tolerated with few overall complications and rare serious complications indicating a safety profile which compares favourably with other liver-directed and surgical therapies for the treatment of liver tumors. Long-term follow-up data including oncologic outcomes are being collected.
Click here to read the full paper.
If you don’t know much about Histotripsy, read on.
16th Dec 2024 – HistoSonics Edison® Histotripsy System Treats First Pancreatic Tumor Patients in GANNON Trial
Histotripsy is expanding, another trial opens for Pancreatic Cancer. Entitled “The HistoSonics Edison™ System for Treatment of Pancreatic Adenocarcinoma Using Histotripsy (GANNON)”
Click here to read
24th Nov 2024 – Histotripsy is expanding, another trial opens for Pancreatic Cancer
Histotripsy is expanding, another trial opens for Pancreatic Cancer. Entitled “The HistoSonics Edison™ System for Treatment of Pancreatic Adenocarcinoma Using Histotripsy (GANNON)”
Click here to read
12th November 2024 – New Trial opens in Hong Kong
Histotripsy is expanding, another trial opens for cancers in the liver, including secondary Neuroendocrine Tumours (liver metastases).
Click here to read
28th October 2024 – HistoSonics® Awarded Exclusive Contract with Veterans Affairs for Tumor Destroying Histotripsy Systems
An exclusive contract to provide Veteran’s Affairs hospitals across the United States access to their novel non-invasive tumour liquefying platforms. The contract, the work of the Veterans Health Administration (VHA) and the Strategic Acquisition Center (SAC) , establishes a $90 million ongoing schedule to develop histotripsy programs at key VA Hospitals. The announced VA contract is the culmination of a multi-year effort by HistoSonics, the company called Project Hero, to ensure meaningful value for Veterans and their families, VHA clinicians, administrators, and caregivers.
Click here to read more.
22nd October 2024 – Video Q&A from Dr Kevin Burns – top Histotripsy expert
This was hosted by a melanoma patient who’s had Histotripsy but still relevant to anyone undertaking the treatment.
Click here to watch
11th October 2024
#HOPE4LIVER Clinical Trial data in Europe finally resolved
Limitations and Caveats
Due to completion of the primary analysis in #HOPE4LIVER US (NCT04572633) that included powered efficacy and safety hypothesis testing on combined US and EU/UK participants, #HOPE4LIVER EU/UK trial enrollment was stopped early. Therefore, there is an insufficient number of target participants needed to achieve target power and statistically reliable results for the primary endpoints for #HOPE4LIVER EU/UK.
Click here to read and check .
4th September 2024
#HOPE4LIVER Clinical Trial data now available
HistoSonics® Publishes Results of its Pivotal #HOPE4LIVER Trials
Adoption of its Novel Non-Invasive Therapy Surges After FDA Clearance.
Click here to read.
Note from the US Clinical Trial document “The #HOPE4LIVER US trial required pooling data from #HOPE4LIVER US and #HOPE4LIVER EU/UK (NCT04573881). Subjects were treated with the same intervention (HistoSonics System) using identical protocols tailored to the regulatory requirements for each geography.”
4th September 2024
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumours Across Multidisciplinary Users (BOOMBOX: Master Study)
The goal of this observational study is to collect information on the use of the HistoSonics Edison System for the treatment of liver tumours. The main aim is to understand how different patient characteristics and procedural characteristics may affect histotripsy success at 36 hours post-histotripsy procedure. Sub-studies to the BOOMBOX: Master Study will investigate specific populations and/or clinical questions with more stringent enrolment criteria, standardized testing criteria, and/or follow-up schedule. Any participant enrolled in the BOOMBOX: Master Study that also qualifies for a sub-study may enrol in the sub-study in parallel; sub-studies will be described in separate sub-study protocols. The BOOMBOX: Master Study will collect information about participants before, during, and after the histotripsy treatment procedure. All participants will be followed per standard clinical follow-up based on each site’s clinical practice for up to 5 years after the initial histotripsy procedure or until completion of their follow-up in a sub-study, whichever is longer.
Read the clinical trial document by clicking here.
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.
Is Histotripsy right for Neuroendocrine Cancer patients?
Firstly, you need to remember that this is not a treatment just for Neuroendocrine Cancer, it was developed to treat tumours no matter where they are and what type they are. It is currently (as at 14th March 2025) only approved for liver tumours.
Secondly, you need to remember that because it is new, there’s a lot of hype surrounding the treatment – this will take time to settle as data starts to come out. My advice for people in the NET community is to be cautious of the hype but also be optimistic that doctors will get better with experience of treating using this system and will be able to find the right balance via patient selection and the capabilities of the system.
Thirdly, remember that liver directed treatment is only the start, follow on trials have commenced to pancreas and kidney, with others to follow. It’s too early to say whether this will be suitable to these locations in NET but be optimistic.
Neuroendocrine Cancer is quite ahead of the game when you consider it’s the second most common cancer currently undergoing treatments (January 2025). It’s also clear that the system has limits – it is not a systemic treatment, it is highly focused on individual tumours. It follows that this treatment will not be for everyone.
But be cautiously optimistic at this point.
Check out this page and the questionnaires Histotripsy Tumor Treatment Information | MyHistotripsy
Go straight to where this treatment is live (but currently only for liver)
That’s easy …… Meet Edison! But the background from my original post in 2022 about the treatment and the clinical trials is below – keep reading if interested.
ORIGINAL ARTICLE FROM 2022 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. Histotripsy is mechanical and not thermal.
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, HIFU has been trialled in Neuroendocrine Cancer patients, nor has it been approved for use in the treatment of Neuroendocrine Cancers. However, Histotripsy trials included NET patients and some are now receiving the treatment or are scheduled.
The clip from BBC below confirms a NET patient is on the trial.
Histotripsy vs Liver Directed Therapy
Trans arterial therapy such as liver embolisation treat through through the artery that goes to the tumour to either block off the blood to the tumour (bland) or deposit radioactive particles (TARE) or chemo (TACE) into it. This is not an ablative technique.
Ablations directly target a tumour to destroy it with heat, cold and now non invasive techniques such as Histotripsy. Some liver masses would be candidates for all types of procedures but certain tumour locations and sizes will be better for trans arterial therapies instead of ablations, will be specific to what your tumour looks like – this will become clear as Histotripsy is used more. Currently Histotripsy is only authorised for liver but other locations are in the pipeline, e.g. pancreatic cancer trials begin in 2024 (watch this blog for announcements).
Human Clinical Trials of Histotripsy – Liver
There are/were trials in Europe and US for Liver.
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.
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. 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.
Human Clinical Trials of Histotripsy – Kidney
A trial in Leeds UK. This is one of the liver locations from the trial above.
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 below.
4th May 2023 – UK Kidney tumour trial treats patients
A cancer patient from West Yorkshire has become the first person in the world to have a kidney tumour removed using Histotripsy.
Anthony Harris, 73, agreed to be a “guinea pig” for the ground-breaking treatment, called histotripsy, at Leeds Cancer Centre.
Click here or on the photo above to watch this amazing video report (note, certain country restrictions may prohibit the viewing of this clip from UK TV).
Another UK kidney patient is also featured here
Human Clinical Trials of Histotripsy – Pancreas
The study below commences in 2024 but the document suggests only for pancreatic adenocarcinoma (regular Pancreatic Cancer) but I have contacted the trials team for confirmation if Neuroendocrine Cancers of the Pancreas can be included.
16th Dec 2024 – HistoSonics Edison® Histotripsy System Treats First Pancreatic Tumor Patients in GANNON Trial
Histotripsy is expanding, another trial opens for Pancreatic Cancer. Entitled “The HistoSonics Edison™ System for Treatment of Pancreatic Adenocarcinoma Using Histotripsy (GANNON)”
Click here to read
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 still early days for Neuroendocrine Cancer. Hopefully we will shortly hear from those on the liver trial and/or US approved hospitals.
For the hope angle, read the story of 68-year-old Sheila Riley from UK – click here
What is the approved treatment called?
That’s easy …… Meet Edison!
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. Some content may be generated by AI which can sometimes be misinterpreted. Please check any references attached.
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.
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.
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
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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.