RecruitingPHASE2INTERVENTIONAL

68Ga-DOTATATE Neuroblastoma Imaging Pilot

Neuroblastoma is a common childhood cancer. Doctors use different scans to understand how far it has spread and to guide treatment. Sometimes these scans give different information, which can make it harder to decide the best treatment plan. This study is testing a new type of advanced scan, called 68Ga-DOTATATE PET/CT, in children and young adults aged up to 21 who have neuroblastoma or are suspected of having it. The main goal is to check if this new scan is safe and works well. Researchers will compare the results of the new scan with the standard 123I-MIBG scan to see if it provides clearer or more helpful information about the cancer. This information could help doctors make more accurate treatment decisions in the future.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Enrolment target

Start

06 Dec 2021

Estimated completion

30 Sep 2028

Neuroblastoma

What is this study about?

Neuroblastoma is the most common type of cancer that develops outside the brain in children. When a child is diagnosed, doctors need to know exactly where the cancer is and if it has spread. They do this using different types of scans like CT, MRI, and other special scans. However, sometimes these different scans don't always show the same picture, which can make it tricky for doctors to choose the best treatment approach.

This study is looking into a new, more advanced scanning technique called 68Ga-DOTATATE PET/CT. This scan uses a special, very small amount of a radioactive substance that helps certain types of cancer cells show up clearly on the pictures. The aim is to see if this new scan can give doctors a better and clearer view of neuroblastoma compared to the scanning method currently used, which is called 123I-MIBG. By getting clearer pictures, doctors might be able to plan treatments more effectively.

The study will involve children and young adults who have been diagnosed with neuroblastoma or are thought to have it. They will have both the standard 123I-MIBG scan and this new 68Ga-DOTATATE PET/CT scan. Researchers will then carefully compare the results from both scans to understand how helpful the new method is. The study also wants to make sure that the new scan is safe for patients.

Key takeaways

This study is testing a new scanning method for neuroblastoma.
It aims to see if the new scan is safe and provides clearer pictures than current methods.
Participation involves one extra scan of about 2 hours.
The study is for children and young adults up to 21 years old with neuroblastoma.
Information from your medical records will be followed for up to 2 years.

Who may be eligible?

This study is open to children and young adults from birth up to 21 years old who have neuroblastoma, either newly suspected or confirmed, or if their neuroblastoma has come back.

To join, you or your child must already be scheduled to have a standard 123I-MIBG scan. An adult (either the participant if they are an adult, or a parent/legal guardian for a child) must be able to understand and sign a consent form in English or French.

There are some reasons why you or your child might not be able to join. These include having had another type of cancer (other than certain non-serious skin cancers) in the last five years, currently being in another study where the treatment is unknown, or if you are currently receiving cancer treatment. Also, if there has been any surgery or treatment to the tumour between your planned 123I-MIBG scan and the new scan, you wouldn't be able to take part. Being medically unwell and unable to have the scan, or if you are pregnant, would also exclude participation. If you are breastfeeding, you would need to stop for at least 12 hours after the new 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.

Is the person with neuroblastoma aged between 1 day and 21 years?
Do they have newly suspected neuroblastoma, a confirmed diagnosis, or has it returned?
Are they already due to have a standard 123I-MIBG scan?
Can an adult (the participant or a parent/guardian) understand and sign a consent form?
Are they currently not receiving active cancer treatment?
Have they not had another cancer diagnosis in the last 5 years (excluding certain skin cancers)?

Answer every question to see your result.

What does participation involve?

If you or your child decide to take part, you will have a 68Ga-DOTATATE PET/CT scan a few days after your planned 123I-MIBG scan. This new scan will take about 2 hours to complete. During this time, a small amount of a special liquid will be given, and then the scan will take pictures. The doctors will also collect information from your existing medical records, including details about your health, any treatments you've had, and other test results. This information will be followed up for a period of up to 2 years after the scan.

Potential risks and benefits

The main benefit of taking part is helping doctors learn more about neuroblastoma and potentially improve how it's diagnosed in the future. This new scan could lead to better treatment planning. As with any medical procedure, there are some potential risks, mainly from the very small dose of radiation involved in both scans. There's also a small chance of an allergic reaction to the substances used in the scan, especially if you've had reactions to similar medicines before. You will be closely monitored during and after the scan. It's very important to remember that taking part in any study is completely your choice, and you are free to withdraw at any time without it affecting your medical care.

Locations (3)

McGill University Health Center - Children's hospital
Verified postcode
Montreal, Canada· Withdrawn
CHU Ste-Justine
Verified postcode
Montreal, Canada· Recruiting
CIUSSS de l'Estrie-CHUS Hospital
Verified postcode
Sherbrooke, Canada· Recruiting

Common questions

What is neuroblastoma?

Neuroblastoma is a type of cancer that usually starts in nerve cells outside the brain, most often in young children.

What is the new scan, 68Ga-DOTATATE PET/CT?

It's an advanced imaging test that uses a special, very small amount of a mildly radioactive substance to help doctors see neuroblastoma cells more clearly than standard scans.

Is the new scan safe?

The study aims to check the safety of this new scan. It involves a very small amount of radiation, similar to other medical scans.

How long will I/my child be involved in the study?

You'll have one extra scan (lasting about 2 hours) a few days after a standard scan, and then your medical information will be followed up for up to 2 years.

Do I have to take part?

No, taking part is completely voluntary. Your decision will not affect your or your child's medical care.

How to find out more

Amelie Tetu, MSc

amelie.tetu.ciussse-chus@ssss.gouv.qc.ca 819-346-1110 Official trial record

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