Active not recruitingOBSERVATIONAL

DOTATOC PET/CT for Imaging NET Patients

This study is testing a new scanning method, called 68Ga-DOTATOC PET/CT, to see how well it finds and monitors neuroendocrine tumours (NETs) and other specific types of abnormal growths. NETs are types of cancer that usually grow slowly but can sometimes be more aggressive. The study wants to investigate if this new scan is more effective and safer than the scans currently used. Researchers believe that certain cells in these tumours have special features that the new scan can pick up better. Participants will have two different scans, and doctors will follow up on their health and treatment progress for up to three years to see how useful the new scan is.

At a glance

Status

Active not recruiting

Sponsor

British Columbia Cancer Agency

Enrolment target

800

Start

11 Jul 2018

Estimated completion

30 Sep 2028

Neuroendocrine Tumors Insulinoma Gastrinoma Glucagonoma Vipoma Pheochromocytoma Paraganglioma Neuroblastoma Ganglioneuroma Medullary Carcinoma Pituitary Adenoma Medulloblastoma Merkel Cell Carcinoma Small-cell Lung Cancer Meningioma Carcinoid

What is this study about?

This study is looking into a new way to scan for certain types of abnormal growths, often called neuroendocrine tumours (NETs). These tumours can develop in different parts of the body and, while often slow-growing, some can be more serious or harder to treat. The cells in these tumours often have a lot of special 'receptors' on their surface, like tiny antennae, which the new scan is designed to find.

Currently, doctors use a few different ways to find and check on these tumours. This study aims to see if a new scan, called 68Ga-DOTATOC PET/CT, is better than the methods commonly used now. The researchers want to firmly establish if this new scan is safe and more accurate in detecting these tumours and other similar conditions where cells have many of these special receptors. If it works well, it could help doctors get a clearer picture of these conditions, leading to better care.

It's important to understand that this study is about gathering more information on how well the new scan works. The findings will help doctors decide if 68Ga-DOTATOC PET/CT offers a valuable improvement in diagnosing and managing these conditions for patients in the future.

Key takeaways

Tests a new scan (68Ga-DOTATOC PET/CT) for neuroendocrine tumours.
Compares the new scan to a standard scan to see if it's better.
Participation includes two scans and health follow-up for up to 3 years.
Aims to improve how these conditions are detected and monitored.
Suitable for adults diagnosed with specific neuroendocrine or similar tumours.
Careful monitoring for safety throughout the study is a priority.

Who may be eligible?

To join this study, you would generally need to be an adult between 18 and 100 years old. You should feel well enough to manage the study's requirements and be able to give your informed consent. This means being able to understand what the study involves and agreeing to take part.

Doctors are looking for people who need scans for specific conditions. These include neuroendocrine tumours, which can affect different body parts like the gut, pancreas, or lungs. They are also looking for people with other specific growths such as certain thyroid tumours, pituitary tumours, or certain skin and brain cancers. The key is that your doctor needs imaging to either find out the extent of your condition initially or to check on it again.

However, some people won't be able to join. For example, if you are pregnant or have a serious, unstable medical condition like severe heart or breathing problems, you would not be eligible. There are also practical limits, such as not being able to take part if you weigh more than the scan bed allows (over 204.5 kg) or if you cannot fit comfortably into the scanner.

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 between 18 and 100 years old?
Do you need a scan for a neuroendocrine tumour or a similar growth like a pituitary tumour or specific type of lung cancer?
Can you lie still on your back for up to 30 minutes for a scan?
Are you generally well and not pregnant (if applicable)?
Do you fit on a standard scanner bed (weight under 204.5 kg and fit through a 70cm opening)?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will have two special scans. One is the new 68Ga-DOTATOC (pronounced: Gallium-DOTATOC) PET/CT scan, which uses a very small, safe amount of a special substance to highlight the tumour cells. The other scan is an 18F-FDG PET/CT scan, which is a standard type of scan often used. Both scans involve having a small injection and then lying still for up to 30 minutes in a scanning machine where images are taken. The substances used in these injections are carefully prepared and approved for research or medical use.

Before your scans, you'll be asked to fill out a medical history form. After your first special injection, the study team will check your vital signs (like blood pressure and heart rate) to make sure you're feeling okay. Then, about 24 hours later, a member of the study team will call you to ask if you experienced any side effects or unusual feelings. This is to make sure you remain safe throughout the study.

After your scans are complete, the study team will continue to follow your health. This will involve collecting information about any new treatments you might start, results from lab tests, reports from other scans you might have, and your doctor's notes on your condition. This follow-up will continue for up to three years after your scans. Overall, the study expects to enrol patients over about a four-year period.

Potential risks and benefits

Taking part in this study may not directly benefit you, but the information gained could help other patients with similar conditions in the future by improving how doctors find and monitor these tumours. You will receive two advanced scans as part of your involvement. Like any medical procedure involving injections or scans, there are some potential minor risks. These include discomfort from the injection or, very rarely, a reaction to the injected substance. The study team will closely monitor you for any side effects, especially in the 24 hours after an injection. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

BC Cancer
Verified postcode
Vancouver, Canada

Common questions

What is a neuroendocrine tumour (NET)?

NETs are a type of cancer that starts in cells in the body that have characteristics of both nerve cells and hormone-producing cells. They can occur in many different organs.

What does PET/CT stand for?

PET/CT is a combination of two powerful scans: PET (Positron Emission Tomography) which shows the body's activity at a cellular level, and CT (Computed Tomography) which provides detailed pictures of your bones and soft tissues.

Will I get results from my scans?

Yes, your doctor will receive the results from your scans as part of your regular care, as they would with any other diagnostic test.

Are the substances injected for the scans safe?

Yes, both substances are used in carefully controlled amounts. The 68Ga-DOTATOC is specially prepared for this study, and 18F-FDG is a standard, approved substance typically used in medical imaging.

How long will the follow-up last?

The study team will collect information about your health and treatment for up to three years after your scans.