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Clinical Trials for PET

Production of 18F-Fluorodeoxyglucose, commonly referred to as FDG, will begin at the Health Sciences Centre the week of November 30th. The product FDG is used in Positron Emission Tomography, commonly known as PET scans.
Patients with a PET scan appointment may be invited to take part in a clinical trial for the production of the FDG, which is the component that is required for the PET scan. This is another step toward the full licensing of FDG production in Newfoundland and Labrador.

This study is standard practice and a Health Canada requirement. The locally produced FDG must adhere to all the same rigorous requirements as FDG that is produced elsewhere across the country. Participants will use FDG that has been produced locally at the Health Sciences Centre for their PET scan.  Currently, the FDG material is transported into the province. Producing FDG locally will greatly benefit the health of Newfoundlanders and Labradorians and will no longer require Eastern Health to transport FDG into our facility from out of province. Transporting FDG in the province can result in transportation delays and postponed tests. Since these types of testing and scanning services are important in the proper care and management of patients in Newfoundland and Labrador, Eastern Health began offering its PET scans while working on licensing requirements to operate the cyclotron which produces the FDG.

Several clinical experts were recruited to the province including a radiopharmacist, radiochemist, cyclotron engineer, physicist and nuclear medicine physicians. With the construction of the Nuclear and Molecular Medicine Facility in 2017, the province’s first FDG PET program began, successfully navigating the Canadian Nuclear Safety Commission (CNSC) licensing, Health Canada’s clinical trial application processes, and the Research Ethics Board, to where we are today. This program has allowed, and will continue to allow, local access to lifesaving technology which previously was only available to patients that were able to travel outside the province.

Participation in the clinical trial is voluntary, patients may change their mind at any time, and if a patient decides not to participate, the study doctor will discuss alternate treatment options with the patient. This consent form has important information to help patients make their decision. Patients are also advised to contact their health-care team if further discussion is required. Click here to view the consent form.

Frequently Asked Questions

Q: Why do we need local FDG production in Newfoundland and Labrador?

A: Currently, FDG is transported from outside the province to the Health Sciences Centre for use in patients daily. The reason for this is that the “half-life” (the time it takes for half of the material to decay, or basically disappear) of FDG is just under two hours. This means it must arrive at our facility as soon as possible so that sufficient quality is available to scan an appropriate number of patients. This process requires significant costs and can result in transportation disruptions, delays and cancellations of flights which can lead to patients having to be rescheduled.  The production of FDG on site will result in a significant decrease in disruptions to the delivery of service, thereby positively impacting patients in Newfoundland and Labrador.
Q: What other benefits can this program bring to the patients of Newfoundland and Labrador?

A: Since launched in 2017, the intent of the new Nuclear and Molecular Medicine facility has always been to provide access to rapidly developing technology to the people of this province that they would otherwise not have access to. Radioactive materials by their nature decay, eventually disappear, which makes transporting very difficult. There are new imaging and treatment processes being developed every day that patients can access while remaining at home in their own province.
Q: How long will it take for locally produced FDG to become fully approved?  

A: Once the clinical trial is underway, we will begin the process of developing a New Drug Submission (NDS), and at the end of this process, local FDG will be fully approved. This can take on average seven years.
Q: What if you are having a PET scan and have questions or problems?

A: If you have any questions about taking part in this study, talk to the study doctor who is managing the clinical trial on the day of your appointment. You can also contact the clinical trial nurse prior to your appointment. You will be provided this contact information when your appointment is scheduled.
Q: How many patients have been scanned since PET-CT testing started in the province?

A: More than 4,200 patients have received a PET-CT scan.
For Patients Receiving a PET Scan:

Q: What precautions do I have to take after the test? Can I go out and carry my daily routine with family and friends?

A: PET is a safe procedure for which the patient will be in hospital for three to four hours. There are no residual effects or activity restrictions and can carry out their daily routines upon discharge from hospital. Patients are advised to take normal medications, unless they have been instructed otherwise. Patients with diabetes will be given special instructions.
Q: What are the benefits of this FDG PET test compare to other modalities CT, MRI, ultrasound?

A: PET gives physicians insight into the many different processes that occur in the body which otherwise wouldn’t be available from other tests. This type of testing is most commonly used in many different types of cancer to allow for a more sensitively identify sites of disease, assessment of how it responds to therapy, and to determine whether the cancer has returned.
Q: How is FDG administered and will there be irritation/discomfort afterward.

A: FDG is administrated by intravenous injection and no adverse effects are anticipated. Patients will be monitored by research staff throughout the process.
Q: How loud are PET scans. I had an MRI, is it anything like that?

A: Unlike MRI scanners, a PET scan is not a loud procedure and is more like a CT scan.
Q: What if I am claustrophobic?

A: Patients should discuss potential claustrophobia with their doctors prior to arriving for their appointment.  There are processes available to minimize discomfort. However, if patients continue to apprehensive when arriving for their appointment, please advise staff so that they can assist.
Q: How do you accommodate sacral nerve damage or other back issues?

A: Patients should advise of their condition upon arrival to the hospital. Knee propping procedures as well as specialized cushion are available to make patients feel comfortable during the scanning process.
Q: Do I have to fast before my test.

A: Patients will be instructed for how long to fast when their appointment is scheduled, normally for 6 - 12 hours before a PET scan appointment. During this time, patient should not have anything to eat or drink, except for plain water. Chewing gum, eating a breath mint or drinking coloured or flavoured water are also not permitted, as these items will interfere with FDG, resulting in an altered PET scan.

Q: How long does the test take?

A: Patients can expect to be at the Nuclear and Molecular Medicine Department for two to three hours.  It is important for patients to arrive 10 minutes prior to your scheduled appointment time.


Updated Dec 7, 2020