RecruitingPhase IIObservational

A research study testing whether a single dose of [18F]AldoView can produce useful images of adrenal glands allowing identification of participants with and without primary aldosteronism

This study is looking into a new type of imaging scan called AldoView. It's designed for people with high blood pressure caused by a condition called primary aldosteronism (PA). PA happens when small glands above your kidneys, called adrenal glands, produce too much of a hormone. This excess hormone can lead to high blood pressure. Currently, finding the exact part of the adrenal gland causing the problem can be tricky. AldoView uses a special, safe substance that 'lights up' the overactive areas on a scan, helping doctors see them more clearly. The goal is to see if this new scan can help doctors decide on the best treatment, like surgery, more accurately and safely than current methods. This could make diagnosis and treatment of PA much easier in the future.

At a glance

Status

Recruiting

Phase

Phase II

Sponsor

University College London

Enrolment target

120

Start

31 May 2026

Estimated completion

31 May 2028

Primary aldosteronism

What is this study about?

Many people have high blood pressure, and for some, it's caused by a condition called primary aldosteronism (PA). This is where your adrenal glands, which are small glands sitting on top of your kidneys, produce too much of a hormone called aldosterone. This hormone helps control the amount of salt and water in your body. When there's too much, it can lead to high blood pressure and other issues.

The challenge with PA is finding which specific part of the adrenal gland is causing the problem. The areas making too much aldosterone can be very tiny and hard to spot with current tests. Some existing tests are uncomfortable or not always successful. This is where AldoView comes in. It's a new substance that's slightly radioactive, but very safe. When injected, it travels to your adrenal glands and 'lights up' the areas that are overactive on a special scan called a PET/CT scan. This allows doctors to see them much more clearly.

The main aim of this study is to see if AldoView can accurately show which adrenal gland is producing too much aldosterone. If it works well, it could help doctors decide if surgery would be helpful for a patient. Earlier small studies have shown promising results, no major side effects, and that it's well-tolerated. If this study is successful, AldoView could offer a quicker, safer, and more accurate way to diagnose PA and guide treatment for many people in the future.

Key takeaways

Tests a new scan (AldoView) for high blood pressure caused by primary aldosteronism (PA).
Aims to find out if AldoView can accurately locate overactive adrenal glands.
Could lead to safer, faster, and more accurate PA diagnosis and treatment.
Earlier research suggests AldoView is safe and well-tolerated.
Study involves a single AldoView injection and a PET/CT scan, with blood tests and a follow-up call.
No guaranteed direct personal benefit, but findings could help future patients.

Who may be eligible?

This study is looking for adults aged 18 years and older. We are interested in three groups of people: those who have been diagnosed with primary aldosteronism (PA), those with other adrenal gland conditions but not PA, and healthy volunteers who don't have adrenal gland problems or PA.

If you have PA, you should be open to having surgery to remove some of your adrenal gland if your doctor thinks it's the right course of action. It's also important that you can understand the study information and are able to attend appointments. If you are a woman who could get pregnant, you'll need to use reliable contraception during the study and for a short time afterwards. Men will also need to use condoms for a period after the scan.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of primary aldosteronism, or another adrenal condition, or are you a healthy volunteer?
If you have PA, are you open to surgery if your doctor recommends it?
Can you attend appointments and understand study information?
If you are a woman who could become pregnant, are you willing to use reliable contraception during and shortly after the study?
If you are a man, are you willing to use condoms during and shortly after the study?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll visit a hospital department specialising in medical scans. You will receive a single injection of the AldoView substance. After this, you'll have a PET/CT scan, which takes pictures inside your body. You'll also have some blood tests done before and after the scan. You will be able to go home soon after the scan is finished. A few days later, someone will call you to check how you're feeling and if you've had any side effects.

For those participants who have surgery to remove part of their adrenal gland as part of their usual care, the removed tissue will be studied. This helps us confirm what the scan showed and understand how well the treatment worked over time. The total time you'd be involved in the study is quite short, mainly focusing on the day of the scan and the follow-up call.

Potential risks and benefits

While we hope the study will improve how primary aldosteronism is diagnosed and treated in the future, there's no promise of a direct personal benefit to you from taking part. However, if the scan reveals something new or unexpected about your health, your doctor will be informed. For those with PA where other tests haven't been clear, the AldoView results might help your care team make decisions about your treatment. All medical substances can have side effects, but AldoView has been safely used in earlier small studies with no serious problems. You might feel a little discomfort or have a small bruise where you get the injection, or feel slightly lightheaded after lying down for the scan. PET/CT scans use a small amount of radiation, similar to other X-rays, which carries a very small, long-term risk of cell damage. You can stop taking part in the study at any time if you feel uncomfortable or change your mind.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University College London Hospitals NHS Foundation Trust
City only
London, England

Common questions

What is primary aldosteronism (PA)?

PA is a condition where your adrenal glands make too much of a hormone called aldosterone, which can lead to high blood pressure.

What is AldoView?

AldoView is a new substance that helps doctors see overactive areas in your adrenal glands on a special scan, making it easier to diagnose PA.

Will taking part benefit me directly?

There's no guarantee of direct personal benefit, but your participation helps improve future diagnosis and treatment of PA.

Are there any side effects from AldoView?

Side effects are usually mild and short-lived, like slight discomfort at the injection site or temporary lightheadedness. Previous studies found no major side effects.

Where is this study happening?

The study is based at University College London Hospitals Foundation Trust (UCLH) in the UK.

How to find out more

Andrew Tunstell

a.tunstell@ucl.ac.uk - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.