Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

An open-label, multi-center, non-randomized pivotal Phase 3 study to evaluate the efficacy and safety of [18F]florbetaben Positron Emission Tomography (PET) imaging to diagnose cardiac AL amyloidosis

This research is looking at a special type of scan, called a PET scan, to help diagnose a heart condition known as cardiac AL amyloidosis. This condition involves abnormal proteins building up in the heart. The study aims to see how good this particular PET scan, using a substance called [18F]florbetaben, is at finding these protein deposits in the heart. Researchers will compare the scan results with other tests to see how accurate it is. The study also wants to understand if having this scan helps doctors make better decisions about a patient's care. It's for adults with suspected heart amyloidosis and will check the safety of the new scan.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Lantheus Germany GmbH

Enrolment target

169

Start

24 Aug 2022

ATTR Amyloidosis, AL Amyloidosis, Cardiac Amyloidosis

What is this study about?

This research study is about exploring a new way to diagnose a serious heart condition called cardiac AL amyloidosis. This condition happens when abnormal proteins, known as amyloid, build up in your heart, making it harder for your heart to work properly. Currently, diagnosing this can be complex.

The study is using a special type of imaging scan called a PET scan. For this scan, a small amount of a substance called Neuraceq is injected into your body. This substance is designed to attach to the amyloid deposits in your heart. The PET scan then creates pictures that can show where these deposits are, helping doctors see if you have cardiac AL amyloidosis. Think of it like a special dye that highlights the problem areas for the camera to see.

The main goal of this study is to see how accurate and reliable this PET scan is at finding cardiac AL amyloidosis. Researchers will compare the results of the scan with other existing tests and measurements to understand its effectiveness. They also want to find out if getting this scan helps doctors make clearer and quicker decisions about diagnosis and treatment for patients.

Key takeaways

This study uses a PET scan to find heart amyloidosis.
It aims to make diagnosis of cardiac AL amyloidosis more accurate.
The study assesses a new imaging substance called Neuraceq.
It could help doctors make better decisions about patient care.
Open to adults aged 18 and older with suspected heart amyloidosis.

Who may be eligible?

This study is looking for adults who are at least 18 years old. There's no upper age limit, meaning older adults can also take part.

Both men and women can participate in this research.

The study is specifically for people who might have or are suspected of having a condition called ATTR amyloidosis, AL amyloidosis, or cardiac amyloidosis. This means the researchers are focusing on heart conditions caused by amyloid protein build-up.

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?
Are you a man or a woman?
Have your doctors suggested you might have a condition called ATTR amyloidosis, AL amyloidosis, or cardiac amyloidosis?
Are you willing to have an injection and a PET scan?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would have a special PET scan. Before and after the scan, doctors will ask you questions about your health and feelings. They will also do typical medical checks that you might already be familiar with. The Neuraceq substance will be given to you as a single injection before your PET scan. The study mainly involves getting this scan and having some health checks and questionnaires. The total duration of your involvement will depend on the assessment schedule for the scan and related checks.

Potential risks and benefits

Potential benefits of taking part could include helping researchers understand this heart condition better, which might lead to earlier and more accurate diagnoses for future patients. You might also gain a clearer understanding of your own heart health. As with any medical procedure, there are potential risks, mainly from the injection of the Neuraceq substance and the PET scan itself, though these are generally considered low. Your study doctor will explain all potential risks in detail. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

—
Unverified
Spain
—
Unverified
Germany

Common questions

What is cardiac AL amyloidosis?

It's a heart condition where abnormal proteins build up in the heart muscle, making it stiff and hard to pump blood properly.

What is a PET scan?

A PET scan is a type of imaging test that uses a small amount of a special substance to show how your organs and tissues are working.

What is Neuraceq?

Neuraceq is the specific substance injected before the PET scan; it's designed to highlight the amyloid proteins in your heart.

Will I get my scan results?

Your study doctor will discuss how and when you might receive information about your results and what they mean for you.

Is this study safe?

All medical studies have potential risks, but researchers take great care to make them as safe as possible. Your doctor will explain any specific risks to you.