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Enrolling by invitationPHASE3INTERVENTIONAL

Fluorocholine PET/CT Basket Trial

This study is investigating a special type of scan known as a Fluorocholine PET/CT. It's designed to see how accurately this scan can identify and monitor various growths in the body, which could be either harmless (benign) or cancerous (malignant). Up to 2000 patients will take part. For those involved, the main study activity will be having this PET/CT scan after receiving a special tracer. Standard medical care will continue as usual. Researchers will then compare the scan results with other medical information, like X-rays or biopsy results, to understand how effective the Fluorocholine PET/CT scan is.

At a glance

Status
Enrolling by invitation
Phase
PHASE3
Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
Enrolment target
2,000
Start
30 Nov 2022
Estimated completion
01 Jul 2030

What is this study about?

This study is all about understanding a specific type of medical scan called a Fluorocholine PET/CT. Think of it like a very advanced camera that can look inside your body. The researchers want to find out how good this scan is at finding and understanding different kinds of growths or lumps, whether they are harmless (doctors call these 'benign') or potentially serious (doctors call these 'malignant' or cancerous).

They're particularly interested in growths that are known or thought to 'light up' when they absorb a special substance called 18F-fluorocholine. This study will involve a large number of people – up to 2000 patients. By looking at so many different cases, the doctors hope to get a very clear picture of when and how this scan can be most useful.

The main goal is to compare the results of this scan with what doctors usually find out through other tests, like X-rays, MRI scans, or even tissue samples (biopsies). This helps them confirm just how accurate and helpful the Fluorocholine PET/CT scan truly is for diagnosing and managing conditions in real-world healthcare.

Key takeaways

  • This study is testing a special PET/CT scan.
  • It aims to see how well the scan finds and checks on various growths.
  • Participants will have one special scan as part of the study.
  • Your regular medical care will continue as usual.
  • There are no direct personal medical benefits from taking part.
  • You can stop participating at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and already be under a doctor's care for a health issue. You should be able to understand what the study involves and agree to take part in writing. You also need to be able to lie still for up to 30 minutes for the scan and have an injection in your arm.

Crucially, you must have a known or suspected growth (either harmless or cancerous) that doctors believe might show up on this specific type of scan based on current medical knowledge.

However, there are reasons you might not be able to join. For example, if you're very unwell at the time (like having serious heart or breathing problems), if you're too heavy for the scanner bed, or if you get very anxious in small, enclosed spaces (severe claustrophobia) which would make the scan difficult for you.

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.

  1. Are you 18 years old or older?
  2. Are you currently under a doctor's care for a health condition?
  3. Can you comfortably lie still for approximately 30 minutes?
  4. Do you have a known or suspected growth that doctors think this scan might help to see?
  5. Are you generally feeling well enough to have a scan (not acutely unwell)?
  6. Do you not suffer from severe claustrophobia (fear of small spaces)?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your regular medical care will continue as normal, just as if you weren't in the study. The only extra step specifically for the study will be undergoing one Fluorocholine PET/CT scan. Before the scan, you'll receive a small, safe injection of a special substance called 18F-fluorocholine into a vein, usually in your arm. After this, you will have the PET/CT scan itself, which involves lying still for about 30 minutes. There are no other visits, medications, or long-term follow-up appointments directly related to the study beyond your usual care. The total duration of your active participation, beyond your regular medical appointments, is essentially limited to the day of your scan.

Potential risks and benefits

This study aims to assess a diagnostic scan, not to provide direct treatment, so there are no anticipated direct medical benefits to you from participating. However, the information gained could help doctors better understand and use this scan for future patients. Potential risks are generally low and associated with the scan itself, such as a needle prick for the injection, a very small dose of radiation (similar to other diagnostic scans), and the need to lie still. You can, of course, withdraw from the study at any time without affecting your medical care.

Locations (1)

  • Jewish General Hospital
    Verified postcode
    Montreal, Canada

Common questions

What is 18F-fluorocholine?

It's a special, safe substance that's injected into your body. It helps certain types of cells and growths 'light up' on the PET/CT scan.

What's a 'benign' tumour?

A benign tumour is a growth that is not cancerous and usually doesn't spread to other parts of the body.

What does a 'phase III' trial mean?

Phase III trials are usually the final step before a new medicine or diagnostic tool can be widely used. They involve many people to confirm safety and effectiveness.

Will I get my scan results?

The study focuses on how effective the scan is overall. Your usual doctor will share any results relevant to your care as part of your standard medical management.

Do I have to pay to be in the study?

No, all study-specific procedures, like the Fluorocholine PET/CT scan, are covered by the study.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "Fluorocholine PET/CT Basket Trial…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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