RecruitingNAINTERVENTIONAL

Heart Analysis in GATED-PET in Patients Having a Gallium-68-DOTATOC PET/CT Exam for Oncology Indication

This study aims to understand links between heart health and heart inflammation. Researchers are inviting people who are already having a special type of scan called a Gallium-68-DOTATOC PET/CT for neuroendocrine tumours. During this routine scan, they will also take extra pictures of the heart using a technique called 'ECG-gated PET imaging'. This extra scan helps to see the heart's movement more clearly. The team wants to find out if this special heart scan can reveal any heart issues that might be connected to a person's age or known risk factors for heart disease. This could help doctors understand heart problems better in the future.

At a glance

Status

Recruiting

Phase

Sponsor

Central Hospital, Nancy, France

Enrolment target

Start

02 Feb 2023

Estimated completion

26 Aug 2025

Cardiac Inflammation

What is this study about?

Imagine your heart, like any part of your body, can sometimes get inflamed. This study is trying to learn more about this 'cardiac inflammation' in people who are already having a specific type of scan for a neuroendocrine tumour. This scan uses a special tracer called Gallium-68-DOTATOC, which helps doctors see certain cells in the body. Interestingly, this tracer can also attach to inflamed cells, including those in the heart.

Researchers want to add a special, non-invasive heart scan during your regular appointment. This extra scan is called 'ECG-gated PET imaging'. It works a bit like taking a video of your heart as it beats, giving doctors a clearer picture of its structure and any potential inflamed areas. The main idea is to see if these extra heart pictures can pick up on problems that might be linked to your age or other things that increase your risk of heart disease, like high blood pressure or cholesterol.

By taking these extra heart pictures, the research team hopes to better understand how cardiac inflammation might show up and what factors could be connected to it. This knowledge could help doctors in the future to identify and potentially treat heart problems earlier or more effectively. It's about gathering important information to improve our understanding of heart health.

Key takeaways

The study looks at heart inflammation using a special scan.
It's for people already having a PET/CT scan for a neuroendocrine tumour.
A small blood test and an extra heart scan are done during your routine appointment.
No extra visits and no changes to your planned cancer care.
Aims to improve future understanding of heart problems, not for immediate personal benefit.
Participation is voluntary and you can withdraw at any time.

Who may be eligible?

You might be able to take part in this study if you are at least 18 years old and are already scheduled to have a Gallium-68-DOTATOC PET/CT scan because your doctor suspects or is checking on a neuroendocrine tumour. It's really important that you understand what the study involves and are happy to sign a consent form, confirming you want to take part. You also need to be covered by a social security scheme.

However, you won't be able to participate if you've had a bad reaction to Gallium-68-DOTATOC before. Your participation would also not be possible if you have severe kidney problems, have been diagnosed with Cushing's syndrome, or are currently pregnant, breastfeeding, or could become pregnant. If you have a history of heart disease, a very irregular heartbeat that would prevent the scan from working properly, or are currently taking a specific type of medication called a somatostatin analogue, you would also be unable to join.

Finally, if for any reason you are unable to give your consent, perhaps due to a legal protection measure, mental health care, or if you are not able to communicate your consent clearly, then you would also not be able to join the study.

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 scheduled for a Gallium-68-DOTATOC PET/CT scan for a neuroendocrine tumour?
Do you understand what the study involves and are you happy to sign a consent form?
Do you *not* have a history of serious heart disease or severe kidney problems?
Are you *not* pregnant, breastfeeding, or taking a somatostatin analogue medication?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your participation will happen during your routine Gallium-68-DOTATOC PET/CT scan appointment. First, after you've signed the consent form, a small blood sample will be taken. This blood sample will be checked for specific markers related to heart health and inflammation. Then, you will receive the Gallium-68-DOTATOC infusion as planned for your tumour scan.

Immediately after this, while you are having your standard PET/CT scan, an additional, special heart scan will be performed. This is the 'ECG-gated PET imaging' and will happen at the same time, without needing a separate appointment. There are no extra hospital visits required beyond your already planned PET/CT scan. The total duration of your involvement in the study is just the time it takes for this one appointment.

Potential risks and benefits

There is no direct personal benefit expected from taking part in this study, but the information collected could help doctors better understand and treat heart inflammation in the future. The risks are very low, as the study adds a specific type of heart imaging during an already scheduled scan and takes a small blood sample. You will receive very small additional radiation exposure from the Gated-PET which is within legal limits. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Veronique Roch
Verified postcode
Vandœuvre-lès-Nancy, France· Recruiting

Common questions

What is Gallium-68-DOTATOC?

It's a special substance used in a type of scan to help doctors see certain cells in your body, usually for neuroendocrine tumours.

What does 'cardiac inflammation' mean?

It means your heart muscle has become inflamed, like when other parts of your body get swollen or irritated.

Will I get extra radiation from this study?

Yes, there will be a very small, additional amount of radiation from the extra heart scan, but it's kept well within safety limits.

Will this study change my cancer treatment?

No, this study is for research only and will not affect the diagnosis or treatment you receive for your neuroendocrine tumour.

How long does taking part actually take?

Your participation happens during your single, already scheduled PET/CT scan appointment. No extra visits are needed.

How to find out more

VERONIQUE ROCH, MSc

v.roch@chru-nancy.fr 03 83 15 42 76 Official trial record

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