Ongoing, recruitingTherapeutic use (Phase IV)Interventional

A Multicentre Surveillance Study to Evaluate the Long-term Safety in Participants who Have Been Previously Treated with 177Lu-IPN01072 in an Ipsen-sponsored Clinical Study

This study is gathering information on the long-term safety of a specific treatment called 177Lu-IPN01072 for a type of cancer known as neuroendocrine tumours (NETs). If you have previously received this treatment in another Ipsen-sponsored study, this research might be for you. The main goal is to check if participants develop any new cancers (either blood-related or other types) in the years following their original treatment. We will also monitor any side effects, changes in blood test results, and overall health. This helps doctors understand the treatment's full effects and how best to use it in the future, ensuring patient safety is always a top priority.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Ariceum Therapeutics GmbH

Enrolment target

Start

07 Oct 2024

Somatostatin Receptor Positive Neuroendocrine Tumours (NETs)

What is this study about?

This study is looking into the long-term effects of a cancer treatment called 177Lu-IPN01072. This treatment is used for a type of cancer known as neuroendocrine tumours, often shortened to NETs. If you've been treated with 177Lu-IPN01072 in a previous study run by the company Ipsen, this new study wants to check in on your health over a longer period.

The main thing we want to understand is whether people who have had this treatment might develop any new cancers later on. These new cancers could be related to the blood (like leukaemia) or other types of cancer. By carefully tracking this, doctors can get a better picture of the full safety profile of the treatment.

We will also be keeping an eye on other important health details, such as any side effects you might experience, changes in your blood tests (which can show how your body is doing), and your general health over time. This helps us ensure that the treatment is as safe as possible and helps doctors make the best decisions for patients in the future.

Key takeaways

This study is about the long-term safety of a specific NETs treatment.
It's for people who have already had 177Lu-IPN01072 in a previous Ipsen study.
The main aim is to check for any new cancers developing years after treatment.
Participants will not receive further treatment doses in this study.
Regular health check-ups and blood tests will be part of the follow-up.
Your involvement helps improve future patient care and safety.

Who may be eligible?

This study is for adults aged 18 or older.

Crucially, you must have previously received the treatment called 177Lu-IPN01072 as part of an earlier clinical study that was sponsored by the company Ipsen. This study is specifically designed to follow up with people who have already had this particular treatment.

Both men and women can take part in this research.

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?
Have you been previously treated with 177Lu-IPN01072?
Was that treatment given as part of an Ipsen-sponsored clinical study?
Are you able to attend regular follow-up appointments?
Are you willing to have your health monitored over a long period?

Answer every question to see your result.

What does participation involve?

If you join this study, it's mainly about monitoring your health over time. This means you won't be given any new medication as part of *this* study. Instead, the doctors will keep track of your health, noting any new health problems, especially any new cancers. This will involve regular check-ups, which may include blood tests and discussions about your overall well-being. The study will continue for a long period to observe long-term effects, so it will involve ongoing communication and occasional visits over several years.

Potential risks and benefits

The main benefit of participating is helping medical science better understand the long-term safety of 177Lu-IPN01072, which can improve care for future patients with NETs. You won't receive extra treatment in this study, but your health will be carefully monitored, which might offer some reassurance. As with any study, there's always a small chance of unforeseen risks, but the core activity of this study is observation. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

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

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Unverified
France

Common questions

What is a 'neuroendocrine tumour'?

Neuroendocrine tumours (NETs) are a group of uncommon cancers that can grow anywhere in the body, but are often found in areas like the gut, pancreas, or lungs.

Why is this study only for people who've had the treatment before?

This study is a 'follow-up' – it helps doctors understand the long-term effects of a treatment that patients have already received, focusing on safety over many years after they finished their initial treatment.

Will I get more of the 177Lu-IPN01072 treatment in this study?

No, this study is purely for observation. You will not receive any new treatment with 177Lu-IPN01072 as part of this research.

What does 'second primary malignancies' mean?

It means the study is looking for whether a person develops any *new* and *different* types of cancer that are not directly linked to their original neuroendocrine tumour, or that occur in a new location.

Who is Ipsen?

Ipsen is the pharmaceutical company that developed and sponsored the original clinical study for 177Lu-IPN01072, and they are sponsoring this follow-up safety study.