Clinical Trial for FDG
Background
With the construction of the Nuclear and Molecular Medicine facility in 2017, the province’s first FDG PET program began, following the Canadian Nuclear Safety Commission (CNSC) licensing, Health Canada‘s clinical trial application processes, and approval from the Newfoundland and Labrador Research Ethics Board.
Production of 18F-Fluorodeoxyglucose, commonly referred to as FDG, began at the Nuclear and Molecular Medicine facility in November 2020. The product FDG is used in Positron Emission Tomography, commonly known as PET scans, and it is currently being produced under Health Canada clinical trial.
All new producers of FDG across Canada have gone through the clinical trial process, as it is a requirement of Health Canada. Because of this, locally produced FDG must adhere to the same rigorous requirements as FDG that is produced elsewhere across the country. This is another step toward the full licensing of FDG production in Newfoundland and Labrador.
How to participate
Patients with a PET scan appointment will be invited to take part in this clinical trial. If patients agree to participate, they will receive FDG that has been locally produced for their PET scan.
Participation in the clinical trial is completely voluntary, and patients may opt out at any time during the process.
As a patient, before you decide whether to participate in the clinical trial:
- please feel free to ask members of the research team, including the study physician, any questions you may have.
- you can access a consent form to take part in the trial before arriving in the department, by following this link clinical trial consent form (PDF). The clinical trial consent form has important information to help you make a decision. You will be asked to complete the consent form prior to receiving FDG.
In the end, if you decide not to participate, you are encouraged to discuss other options with your health-care team.
Benefits of the trial
Since launched in 2017, the Nuclear and Molecular Medicine facility continues to work to provide access to rapidly developing technology to the people of this province that they would otherwise not have access to. New imaging and treatment processes are being developed every day that patients can access while remaining at home in their own province.
Radioactive materials by their nature decay, eventually disappear, which makes transportation difficult. The ability to produce FDG onsite, leads to a much more stable supply of product resulting in fewer disruptions to delivery of the service as well as increased access. This positively impacts patients in Newfoundland and Labrador by decreasing the number of cancelled and delayed scans.
This program provides local access to lifesaving technology which which before 2017 was only available to patients who were able to travel outside the province.
Several clinical experts were recruited to the province including a radiopharmacist, radiochemist, cyclotron engineer, physicist, and nuclear medicine physicians. This has resulted in ancillary benefits to other areas of the Nuclear and Molecular Medicine Program, which has seen an improved level of service due to the presence of this expertise which was not available previously. These experts have also contributed elsewhere, for example in the areas of research and education, making a significant difference in the Memorial University of Newfoundland community.
With the clinical trial currently underway, the next step will be to begin the process of developing a New Drug Submission (NDS), and at the end of this process, local FDG will be fully approved and the clinical trial will no longer be required. This process can take up to seven years.
Questions
If you have any questions about taking part in this study, please talk to the research team, including physician who is overseeing the clinical trial, on the day of your appointment. You can also contact the clinical trial nurse prior to your appointment. This contact information will be provided when your appointment is scheduled.
For more information about clinical trials at Eastern Health, please visit Research and Innovation – Clinical Trials.