Total Body PET/CT: A Role in Drug Development?

Area of Science:

• Medical Imaging
• Radiopharmaceutical Science
• Pharmacokinetics

Background:

• Total body PET (positron emission tomography) offers advanced imaging capabilities, particularly high sensitivity, now available in medical centers.
• Its potential in clinical radiopharmaceutical evaluation is underexplored, despite unique challenges in drug development and regulatory processes.
• Current methods for radiopharmaceutical safety and pharmacokinetic studies involve invasive procedures, causing patient discomfort and implementation difficulties.

Purpose of the Study:

• To explore the underexplored potential of total body PET in the clinical evaluation of radiopharmaceuticals.
• To highlight how total body PET can address challenges in radiopharmaceutical development, safety evaluation, and pharmacokinetic studies.
• To discuss the role of total body PET in harmonizing quantitative performance across multi-center clinical trials.

Main Methods:

• Utilizing total body PET for high-quality, quantitative imaging in safety evaluations and internal radiation dosimetry.
• Employing total body PET for noninvasive assessment of radioactive drug concentration in blood vessels to facilitate pharmacokinetic studies.
• Applying parametric analysis with compartment models to total body PET data for in-depth pharmacokinetic insights.
• Considering harmonization requirements for multi-center PET/SPECT research and potential discrepancies with short axial field of view scanners.

Main Results:

• Total body PET provides the quantitative accuracy needed for precise internal radiation dosimetry in radiopharmaceutical safety evaluations.
• Noninvasive assessment of radioactive drug concentration via total body PET significantly improves pharmacokinetic studies compared to invasive sampling.
• Successful clinical trials of novel radiopharmaceuticals (small molecules, peptides, nanobodies, etc.) have already utilized total body PET.
• Parametric analysis using compartment models on total body PET data offers valuable pharmacokinetic information.

Conclusions:

• Total body PET imaging significantly enhances the clinical evaluation of radiopharmaceuticals.
• It addresses key challenges in safety assessment, internal dosimetry, and pharmacokinetic studies.
• Total body PET is poised to revolutionize radiopharmaceutical development and play a critical role in future drug discovery.