The procedure involves a combination of a diagnostic test using a newly developed Medical Research Council-funded (MRC) molecular tracer, a PET scanning method and an endoscopic procedure, known as Targeted Thermal Therapy (Triple T). It has the potential to help many people living with primary aldosteronism.
Chris Miller, a patient who recently underwent Triple T said:
After the procedure, I haven’t had any issues with blood pressure, I’m cured. I thought I could be battling with high blood pressure for the rest of my life and now it’s not a problem.
Primary aldosteronism
High blood pressure affects between a quarter and a third of all adults in the UK. Like Chris, around one in 20 of these cases are due to primary aldosteronism.
The condition occurs when tiny non-cancerous nodules in the adrenal glands produce excess aldosterone, a hormone that raises blood pressure.
Patients often do not respond well to standard blood pressure medications and face higher risks of heart attacks, strokes and kidney failure.
Improving diagnosis and access
At the moment, many patients with primary aldosteronism remain undiagnosed. Even when the condition is diagnosed current tests to determine suitability for surgery are invasive, time-consuming and can only be performed to a high standard in a small number of specialist hospitals in the UK.
Now, researchers at the University of Cambridge, Cambridge University Hospitals NHS Foundation Trust and Uppsala University have developed a new method for precise detection of primary aldosteronism.
Funded by the MRC’s Developmental Pathway Funding Scheme (DPFS), the method uses a molecular tracer that is combined with PET scanning to detect the presence of aldosterone-producing nodules in the adrenal glands.
The PET tracer could become available at most larger hospitals, meaning more people can be diagnosed and receive targeted treatment.
The new PET tracer diagnostic technique
Professor Franklin Aigbirhio, MRC Principal Investigator and Professor of Molecular Imaging Chemistry at the University of Cambridge, said:
Our diagnostic method uses a specially designed molecular tracer, called 18F-CETO, that, when injected into the blood, travels to the aldosterone-producing nodules in the adrenal glands.
This tracer is crucial because it allows the PET scanner to create a detailed three-dimensional image of the nodules to enable more targeted clinical care.
Our aim is to facilitate wider access to this technology by the creation of a national NHS network for molecular imaging of primary aldosteronism.
A faster and safer alternative to surgery
Until now, primary aldosteronism has either been treated through life-long medication or removal of the entire adrenal gland. This surgery requires general anaesthesia, a two to three-day hospital stay, and weeks of recovery.
In the future, once diagnosed, some patients could receive Triple T which uses a small heat-generating needle to destroy specific nodules, identified by the PET tracer, while leaving the surrounding tissue unharmed.
This 20-minute, minimally invasive procedure eliminates the need for incisions, or surgery to remove the adrenal gland.
A study of 28 patients, led by doctors at Queen Mary University of London, Barts Health NHS Trust and University College London, found Triple T to be safe and effective. Most patients had normal hormone levels six months later, with many stopping blood pressure medication with no recurrence of the condition.
Translating research to patient benefit
Professor Mark Gurnell, Clinical Endocrinology Lead at Addenbrooke’s Hospital and Professor of Clinical Endocrinology at the University of Cambridge, who also developed the PET tracer technique and was part of the Triple T trial team said:
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.
Professor Aigbirhio added:
DPFS funding was crucial – it enabled us to progress from the tracer’s experimental data, to undertake first-in-human clinical trials in patients, and then to establish that this new PET imaging technology can be used for improved diagnosis of primary aldosteronism.
A major step forward for NHS high blood pressure treatment
Professor Stephen Pereira, Chief Investigator of the Triple T study and Professor of Hepatology and Gastroenterology at UCL Institute for Liver and Digestive Health, said:
With appropriate training, this less invasive technique could be widely offered in endoscopy units across the UK and beyond.
With further studies underway, this breakthrough treatment could soon become a standard procedure worldwide, transforming care for patients with this curable form of high blood pressure.
Chris Miller’s story
Chris Miller, aged 68 from near Wisbech, was referred to Addenbrooke’s Hospital after more than a decade of health problems. His blood pressure was 50% higher than normal, despite maximum doses of three kinds of medication.
He was diagnosed with primary aldosteronism using the new PET imaging method and was admitted for the Triple T study. Following the procedure, he recovered quickly, and his blood pressure has returned to normal. He no longer needs medication.
Without Triple T, Chris would have needed more invasive surgery to completely remove his adrenal gland, which would have been followed by weeks or even months of recovery.
Chris said:
They tell you to take it easy afterwards, but thanks to this study I was able to go back to normal quickly. I went back to work and was able to get life back to normal. It is great not having to remember to take pills all the time. I’ve now retired and I’m fitter and healthier than ever.
MRC DPFS
DPFS is a cornerstone of our strategic approach to funding translational research.
Our goal is to:
- bridge the gap between fundamental scientific discoveries and their application in clinical setting
- improve patient outcomes and reduce the resource and financial burden on healthcare systems
Further information
The MRC-funded DPFS Phase I/IIa clinical trial results of the radiopharmaceutical 18F-CETO was published in the Journal of Nuclear Medicine earlier this year.
The Triple T clinical trial, called FABULAS, an acronym for ‘feasibility study of radiofrequency endoscopic ablation, with ultrasound guidance, as a non-surgical, adrenal sparing treatment for aldosterone-producing adenomas’, is published in The Lancet.
The technique was developed through a collaboration between researchers at:
- Queen Mary University of London
- Barts Health NHS Trust
- University College London Hospitals NHS Foundation Trust
- University of Cambridge
- Cambridge University Hospitals NHS Foundation Trust
The FABULAS trial was primarily supported by the British Heart Foundation and National Institute for Health and Care Research (NIHR) through the Barts and Cambridge Biomedical Research Centres (BRCs).
The FABULAS trial is being followed by a larger randomised trial, called ‘WAVE’, which will compare this new treatment to traditional surgery in 120 patients. This trial is supported by the British Heart Foundation, Barts Charity and NIHR through BRCs. The results are expected in 2027.
Top image: Credit: Lorena Garibo, iStock, Getty Images Plus via Getty Images