Researchers at NIHR Cambridge BRC instrumental in developing new treatment that offers quick cure for common cause of high blood pressure

Researchers from NIHR Cambridge BRC, University of Cambridge and Cambridge University Hospitals NHS Foundations Trust have developed a vital piece of technology that has dramatically advanced the ability to diagnose primary aldosteronism,  a common cause of high blood pressure.

The UK-based study, which was a multi site collaboration between researchers at Cambridge BRC, Queen Mary University of London, Barts Health NHS Trust  and University College London Hospitals NHS Foundation Trust has led to the development of a simple, minimally invasive Targeted Thermal Therapy (Triple T) that has the potential to transform treatment of this common cause of high blood pressure.

The vital molecular tracer and PET scanning method, that have dramatically advanced the ability to detect this common condition, was developed by researchers in Cambridge.

This breakthrough, published last Friday in The Lancet, could, after further testing, help millions of people worldwide, who currently go undiagnosed and untreated.

A hidden cause of high blood pressure 

High blood pressure affects one in three adults in the UK. Around one in 20 of these are due to primary aldosteronism. However, fewer than one percent of those affected are ever diagnosed as the current diagnostic process includes an invasive, time-consuming procedure that can only be performed in the UK at fewer than a dozen specialist hospitals.

The condition occurs when tiny benign nodules in one or both adrenal glands produce excess aldosterone, a hormone that raises blood pressure by increasing salt levels in the body. Patients with primary aldosteronism often do not respond well to standard blood pressure medications and face higher risks of heart attacks, strokes, and kidney failure.

The new approach dramatically improves the outlook for people with primary aldosteronism by combining a diagnostic PET scan with Triple T.

First, a newly developed molecular tracer is injected into the blood which travels to the nodules in the adrenal gland, where it can be detected using a PET scanner– a high-tech piece of equipment that produces three-dimensional images inside the body. The PET scans take just 10 minutes and could become available at most large hospitals, meaning many more people can be diagnosed.

A game-changing alternative to surgery

Until now, primary aldosteronism has either been treated through life-long medication or via surgical removal of the entire adrenal gland, requiring general anaesthesia, a two- to three-day hospital stay, and weeks of recovery.

In future, once diagnosed, some patients could be offered Triple T which provides a faster, safer alternative to surgery, by selectively destroying the small adrenal nodules without removing the gland. This is currently only possible for nodules in the left adrenal gland which can be see via endoscopy into the stomach, from where they can be directly targeted.

Triple T is also known as endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA). It harnesses the energy of waves, adapting two well-established medical techniques: radiofrequency or microwaves generate heat in a small needle placed into the malfunctioning tissue, causing a controlled burn; ultrasound uses reflected sound waves to create a real-time video of the procedure.

In Triple T, as in routine endoscopy, a tiny internal camera—in this case using ultrasound as well as light—is passed by mouth into the stomach. The endoscopist visualises the adrenal gland and guides a fine needle from the stomach precisely into the nodule. Short bursts of heat destroy the nodule but leave the surrounding healthy tissues unharmed. This minimally invasive approach takes only 20 minutes and eliminates the need for internal or external incisions.

Successful trial shows promise 

The study is called FABULAS, the name being an acronym for Feasibility study of radiofrequency endoscopic ABlation, with ULtrasound guidance, as a non-surgical, Adrenal Sparing treatment for aldosterone-producing adenomas.

FABULAS tested Triple T in 28 patients with primary aldosteronism, whose molecular scan had pinpointed a hormone-producing nodule in the left adrenal gland. The new procedure was found to be safe and effective, with most patients having normal hormone levels six months later. Many participants were able to stop all blood pressure medications, with no recurrence of the condition.

Professor Morris Brown, co-senior author of the FABULAS study and Professor of Endocrine Hypertension at Queen Mary University of London and Professor of Endocrinology at Barts Health NHS Trust, said: “It is 70 years since the discovery in London of the hormone aldosterone, and, a year later, of the first patient in USA with severe hypertension due to an aldosterone-producing tumour. This patient’s doctor, Jerome Conn, predicted, with perhaps only minor exaggeration, that 10-20% of all hypertensions might one day be traced to curable nodules in one or both glands. We are now able to realise this prospect, offering 21st-century breakthroughs in diagnosis and treatment.”

One of the trial participants, Michelina Alfieri, shared her experience:

“Before the study, I suffered from debilitating headaches for years despite multiple GP visits. As a full-time worker and single parent, my daily life was severely affected. This non-invasive treatment provided an immediate recovery—I was back to my normal routine straight away. I’m incredibly grateful to the team for giving me this choice.”

What’s Next? 

The success of FABULAS has led to a larger randomised trial called ‘WAVE’, which is comparing Triple T with traditional adrenal surgery. The results are expected in 2027.

Professor Stephen Pereira, Chief Investigator of FABULAS and Professor of Hepatology & Gastroenterology at UCL Institute for Liver and Digestive Health, added: “With appropriate training, this less invasive technique could be widely offered in endoscopy units across the UK and beyond.”

Clinical Endocrinology Lead at Addenbrooke’s Hospital and Professor of Clinical Endocrinology at the University of Cambridge, Professor Mark Gurnell, said: “This breakthrough was made possible thanks to the collaborative development of novel PET tracer molecules, which enable non-invasive diagnosis by allowing us to precisely locate and treat adrenal nodules for the first time.

“Thanks to this work, we may finally be able to diagnose and treat more people with primary aldosteronism, lowering their risk of developing cardiovascular diseases and other complications, and reducing the number of people dependent on long-term blood pressure medication,” he added.

A major step forward for hypertension treatment 

For the millions of people suffering from undiagnosed primary aldosteronism, this research offers new hope. The potential to be freed from a life of struggling with high blood pressure via simple, non-invasive diagnosis, and safely targeted thermal therapy, allowing faster recovery and better outcomes.

With further studies underway, this breakthrough treatment could soon become a standard procedure worldwide, transforming care for patients with this curable form of hypertension.

Successful trial shows promise 

The study is called FABULAS, the name being an acronym for Feasibility study of radiofrequency endoscopic ABlation, with ULtrasound guidance, as a non-surgical, Adrenal Sparing treatment for aldosterone-producing adenomas.

FABULAS tested Triple T in 28 patients with primary aldosteronism, whose molecular scan had pinpointed a hormone-producing nodule in the left adrenal gland. The new procedure was found to be safe and effective, with most patients having normal hormone levels six months later. Many participants were able to stop all blood pressure medications, with no recurrence of the condition.

Professor Morris Brown, co-senior author of the FABULAS study and Professor of Endocrine Hypertension at Queen Mary University of London and Professor of Endocrinology at Barts Health NHS Trust, said: “It is 70 years since the discovery in London of the hormone aldosterone, and, a year later, of the first patient in USA with severe hypertension due to an aldosterone-producing tumour. This patient’s doctor, Jerome Conn, predicted, with perhaps only minor exaggeration, that 10-20% of all hypertensions might one day be traced to curable nodules in one or both glands. We are now able to realise this prospect, offering 21st-century breakthroughs in diagnosis and treatment.”

One of the trial participants, Michelina Alfieri, shared her experience:

“Before the study, I suffered from debilitating headaches for years despite multiple GP visits. As a full-time worker and single parent, my daily life was severely affected. This non-invasive treatment provided an immediate recovery—I was back to my normal routine straight away. I’m incredibly grateful to the team for giving me this choice.”

What’s Next? 

The success of FABULAS has led to a larger randomised trial called ‘WAVE’, which is comparing Triple T with traditional adrenal surgery. The results are expected in 2027.

Professor Stephen Pereira, Chief Investigator of FABULAS and Professor of Hepatology & Gastroenterology at UCL Institute for Liver and Digestive Health, added: “With appropriate training, this less invasive technique could be widely offered in endoscopy units across the UK and beyond.”

Clinical Endocrinology Lead at Addenbrooke’s Hospital and Professor of Clinical Endocrinology at the University of Cambridge, Professor Mark Gurnell, said: “This breakthrough was made possible thanks to the collaborative development of novel PET tracer molecules, which enable non-invasive diagnosis by allowing us to precisely locate and treat adrenal nodules for the first time.

“Thanks to this work, we may finally be able to diagnose and treat more people with primary aldosteronism, lowering their risk of developing cardiovascular diseases and other complications, and reducing the number of people dependent on long-term blood pressure medication,” he added.

A major step forward for hypertension treatment 

For the millions of people suffering from undiagnosed primary aldosteronism, this research offers new hope. The potential to be freed from a life of struggling with high blood pressure via simple, non-invasive diagnosis, and safely targeted thermal therapy, allowing faster recovery and better outcomes.

With further studies underway, this breakthrough treatment could soon become a standard procedure worldwide, transforming care for patients with this curable form of hypertension.

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02755-7/fulltext

New study to test personalised breast cancer screening

Breast screening - NIHR Cambridge BRC image

A new international trial will investigate whether a personalised breast cancer screening can help detect the disease sooner.

MyPeBS trial is taking place in 6 European countries and plans to involve 85,000 volunteers aged between 50 and 70 who have never had breast cancer before.

Currently those between the ages of 50-70 are invited for a routine NHS breast cancer screening by having a mammogram every three years. However, not everyone has the same breast cancer risk, other factors such as genetics, hormones, family history and breast density can put some in a higher risk category.

The MyPeBS study randomly assigns trial volunteers to follow either the standard NHS screening schedule or a personalised screening schedule according to their risk of breast cancer.

Professor Fiona Gilbert, professor of radiology at University of Cambridge and imaging theme lead for the NIHR Cambridge Biomedical Research Centre is leading the UK study. “This is an opportunity to take part in one of the largest studies so far into how we find early stage breast cancer. By taking a saliva sample and history from those selected on the trial, we can identify whether they are at higher or lower risk of developing breast cancer. Once we know this, we can tailor screening to their own personal needs.”

Cambridge University Hospitals NHS Foundation Trust (CUH), the Leeds Teaching Hospitals NHS Trust and Manchester University NHS Foundation Trust (MFT) will be supporting the UK arm of the study and plans to recruit 10,000 volunteers which will last for 4 years. The Cambridge site will be supported by the NIHR Cambridge BRC.

For more information about the trail, go to: www.mypebs.eu

ITV News reported on the trial in October 2021 or read the full news article.

World first for AI and machine learning to treat Covid patients worldwide

Three nurses looking at a screen - Image from Cambridge University Health Partners

In a ground-breaking study supported by the NIHR Cambridge BRC, Addenbrooke’s Hospital, healthcare technology firm NVIDIA and 20 other hospitals worldwide have used artificial intelligence (AI) to predict Covid patients’ oxygen needs.

In what’s known as federated learning, the research applied an algorithm to analyse anonymised electronic patient health data and chest x-rays from 10,000 Covid patients worldwide, including 250 at Addenbrooke’s Hospital.

The study – dubbed EXAM – took just two weeks of AI ‘learning’ to achieve high-quality predictions on how much extra oxygen a patient would need in the first days of hospital care.

To maintain strict patient confidentiality, the patient data was fully anonymised and an algorithm was sent to each hospital so no data was shared or left its location.

Once the algorithm had ‘learned’ from the data, the analysis was brought together to build an AI tool which could predict the oxygen needs of hospital Covid patients anywhere in the world.

This model can be used to help frontline physicians worldwide.

This is an abridged version of the article first published on our website on 15 September 2021.

 

Well-planned patient preparation before their scans improves imaging quality and cancer detection rates

An NIHR Cambridge BRC-supported review of existing studies has found that adequate preparation of patients with suspected prostate cancer before their MRI scans could significantly improve imaging quality, cancer detection rates and subsequent treatment planning.

Multiparametric magnetic resonance imaging (mpMRI) is a special type of scan that creates more detailed pictures of the prostate. It plays an essential role in the diagnosis of prostate cancer (PCa), and can help doctors decide if tumours are clinically significant (that is, likely to impact on a patient’s life and therefore needing treatment); it is now performed in up to 75% of men with suspicion of PCa in the UK.

Existing guidelines on its use, while they address technical hardware and software and diagnostic considerations, have not to date adequately covered patient-related factors which also can affect the quality of the imaging.

This review from Cambridge radiologists Dr Tristan Barrett and Dr Iztok Caglič looked at how some simple steps can help to further optimise the image quality of mpMRI.

Before mpMRI the authors therefore recommend:

  • Using antiperistaltic agents to minimise spasm in the intestines and associated movement (which can result in blurring of image)
  • Asking patients to empty their bowels prior to examination to minimise image distortion
  • Asking patients to refrain from ejaculation for three days before their scans
  • Using an additional scan sequence called PROPELLER to improve image quality in patients with hip metalwork.

Read the full article: https://doi.org/10.1016/j.crad.2018.12.003

Prostate Cancer Diagnostic Pathways

After skin cancer, prostate cancer is the most common cancer in men, usually affecting those over 50. Researchers in Cambridge have led on MR imaging to better identify tumours within the prostate, coupled with precision biopsy techniques using fusion software.

Clinicians at Cambridge University Hospitals have been working with imaging researchers to carry out Magnetic Resonance Imaging (MRI) targeted prostate biopsies (needles into the prostate to retrieve samples), using MRI-Ultrasound image fusion software.

In 2011, Cambridge was the first centre in the UK to use this technique routinely in the clinical setting, for repeat biopsy in high-risk patients. This practice was subsequently adopted in the 2014 update of the NICE guidelines for prostate cancer. Cambridge researchers developed the Ginsburg group guidelines on how to perform targeted ‘transperineal biopsy’ to allow standardisation of the technique.

The traditional diagnostic pathway of prostate cancer has been changed since 2015; prior to intervention, men now have the MR imaging before undergoing a biopsy.

This pathway has provided clinicians an improved way to identify cancerous tumours in the prostate and has reduced the number of invasive samples being taken and in some cases avoiding a biopsy altogether.

This has allowed clinicians to “get it right first time” and is helping men to be diagnosed faster and start treatment earlier. The Anglian Network Cancer Group has adopted this practice as its Prostate Best Practice Pathway, and NICE have suggested that this practice will form part of their updated 2018 guidelines for prostate cancer diagnosis and management.

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