PET - New tracers - Design of the study
5 important questions on PET - New tracers - Design of the study
What is the target of 11CSMW139?
What is the study design of a new tracer in human?
- Chose a control group that is representable. In oncology patients, you need to select oncology patient but with another type.
- Number of patients is about 5 patient, 5 control. When there is a trend toward something, you go up to 10 to gain more statistical power.
- Think about the scan time (half-life)
- Think about how many becquerel (amount of decay per second)
- Are you adding an arterial line.
What do the amount of becquerel with the quality of the pictures? What also impacts the quality of the picture (5)?
- A high becquerel produces more positron emissions, leading to more annihilation events and gamma-ray detections.
- higher dose also cause more annihilation
- Sensitivity of the detector
- Tracer specificity
- Biological consideration => metabolites
- Long scanning time => more events can be detected
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About what do you need to think for medical ethical approval?
- Study protocol
- Show toxicity documents
- Which laboratory/procedures
- Recruitment material
- Investigators brochure (IB)
– summary clinical/preclinical data on the product
- Investigational Medicinal Product Dossier (IMPD)
– Quality/Production; Safety and Efficacy (IB)
- Insurance
- Curriculum vitae researchers
- Research contracts/ consortium agreement
What about the radiation risk for patients?
- Make an estimation what the exposure is for the participant => low
- At young age the risk is higher compared to older age => multiple reasons: lifetime of the change of developing cancer is smaller when you are older + when you are younger more cell division and development, so more risks.
- Male have lower risk than females
The question on the page originate from the summary of the following study material:
- A unique study and practice tool
- Never study anything twice again
- Get the grades you hope for
- 100% sure, 100% understanding
