Joint Training in Clinical Pharmacology and Imaging

Didactic Sessions in Clinical Pharmacology and Drug Development

• Drug Development: Introduction and Expectations
• Drug Development: The Interdisciplinary Team
• Pharmacogenetics of HNMT, COMT, SULT, & GST
• Drug Development: Toxicology Michael
• Drug Development: Chem/Manufacturing
• Drug Development: Phase 1 trials
• Drug Development: Quantitave Pharmacology
• Drug Development: Biomark/LabMed
• Drug Development:Regulatory/Ethical Environment
• Drug Development: Phase 2/3 Trials
• Methods for Genotyping in Clinical Pharmacogenetics IV
• Pharmacogenetics of drug transport proteins
• Pharmacogenetics of Drug Targets I
• Drug Development: Statistical CT Drivers
• Pgx: Genotyping Array Systems - Amplichip & Tag-IT
• Pharmacogenetics of Drug Targets II
• Drug Development: European Experience
• Principles of Individualized Medicine
• Approach to Individualized Medicine
• Study Design: Clinical Trial Design in Large Epidemiologic Trials of Drug Therapy
• Individualized Medicine-Pain Management
• Individualized Medicine-ID
• Individualized Medicine-Heme/Oncology I
• Individualized Medicine-Heme/Oncology II
• Individualized Medicine-Hypertension
• Individualized Medicine: Ethical Principles and Considerations
• Individualized Medicine-Diabetes/MetabolicSyndrome
• Individualized Medicine-Psychiatry
• Individualized Medicine-Cardiology
• Individualized Medicine-Obstetrics
• Individualized Medicine-Pediatrics
• IRB
• Ethics in Clinical Research (Scientific Integrity)
• Application of MOA to Individualized Medicine

• Development and validation of pharmacogenetic tests for clinical use
• Interpretation of Clinical Pharmacogenetics Tests
• Patient counseling in Pharmacogenetics
• Use of Pharmacogenetics in Drug Development
• Tailored Clinical Trials for Pharmacogenetics (4 lectures)
• IRB issues unique to pharmacogenetic studies
• Statistical Challenges in Pharmcogenetic studies
• Database Development and Data management in Pharmacogenetic Trials
• Ethical issues in the use of pharmacogenetics tests
• Patenting pharmacogenetic tests

1. Basics: physics, chemistry, and camera techniques



1. Historical development of PET
   
   Physics background
   Positron tomographs and detectors for PET
   Quality control
   PET/CT
   


2. Image reconstruction, quantification, and SUV
   
   Reconstruction of radioactivity distribution
   Factors that influence quantitative accuracy
   Coincidence events and acquisition modes
   Dead-time correction
   Correction for random coincidences
   Correction for scattered coincidences
   Attenuation correction
   Choice of filter for filtered backprojection reconstruction
   Quantitative analysis of 18F-FDG PET: tracer kinetic modeling
   SUV
   


3. Partial-volume effects and corrections for brain and whole body



4. Radiation safety in PET
   
   Radiation protection of patients
   Radiation protection of personnel
   Environmental protection
   


5. Biochemical concept and radiochemical synthesis of 18F-FDG
   
   Biochemistry of glucose and 2-deoxyglucose
   Radiochemistry of 18F-FDG
   Validated methods for synthesizing 18F-FDG
   ¹⁸F-FDG quality control
   


6. Current development of 18F-labeled PET tracers
   
   Analogs of 18F-FDG
   Amino acids
   DNA building blocks
   Peptides and steroids
   Bones
   


7. PET and PET/CT
   
   PET imaging protocols
   Challenges of retrospective image alignment
   PET/CT protocols
   Acquisition protocols
   Effects of contrast enhancement
   CT-based quantitative corrections
   Image reconstruction and dual-modality image display
   


8. Physiologic distribution of 18F-FDG, normal variants, and artifacts




2. Oncologic applications
   
   Each type of tumor includes the following topics:
   
   Incidence, etiology, and epidemiology
   Histopathologic classification
   Conventional diagnostic and therapeutic methods
   Roles of 18F-FDG PET and PET/CT
   Technical considerations
   Diagnosis of primary tumors
   Grading
   Initial staging
   Monitoring of therapy
   Diagnosis of recurrence and restaging
   Prognosis
   Impact on management
   
   Other PET radiopharmaceuticals
   
   
   1. Brain tumors
   2. Head and neck tumors
   3. Carcinoma of unknown primary source
   4. Thyroid carcinomas
   5. Lung cancer
   6. Pancreatic cancer
   7. Hepatobiliary tumors
   8. Colorectal carcinomas
   9. Hodgkin's and non-Hodgkin's lymphomas
   10. Testicular cancer
   11. Prostatic cancer
   12. Malignant melanomas
   13. Musculoskeletal tumors and soft-tissue sarcomas
   14. Metastatic bone disease
   15. Renal cell and uroepithelial cancer
   16. Endocrine and neuroendocrine tumors
   17. Breast cancer
   18. Esophageal and gastric cancer
   19. Ovarian and cervical cancer
   20. Pitfalls in interpretation of PET studies
   21. PET in pediatrics
   22. PET and PET/CT in radiation therapy
   23. Monitoring of treatment response with PET and PET/CT
   24. Cost-effectiveness of PET and PET/CT in patient management
   25. Cancer screening with PET and PET/CT


3. Infectious diseases
   
   
   1. Patient preparation and protocols
   2. PET imaging in HIV patients
   3. PET imaging in patients with suspected prosthetic infections


4. Neurologic disease
   
   
   1. Patient preparation and protocols
   2. PET imaging in neurodegenerative disorders
   3. PET receptor imaging


5. Cardiovascular Disease
   
   
   1. Patient preparation and protocols
   2. PET imaging in atherogenesis
   3. PET imaging of myocardial viability, coronary flow reserve
   4. PET assessment of parasympathetic and sympathetic innervation
   5. PET imaging of cardiac fatty acid metabolism