Precision Imaging: Quantitative, Molecular, and Image-Guided Technologies

• Directors: Drs. David Schuster and Hui Mao
• Objective: Introduction to the basics of human translation of a radiotracer.

1. Meet with assigned faculty and clinical research staff. Contact Dr. Krupinski to arrange a meeting for Wednesday of this week; if not possible, arrange another time.
2. Read two key papers on fundamentals of translation including FDA/IND and view three PowerPoint presentations (may also be completed in advance or after hours) available online below.

a) Presentations (view in this order):

1. Clinical Research in Imaging (90 minutes)
2. Navigating the Regulatory Shoals: Transitioning Your Imaging Agent to the Clinic
3. Everything You Need to Know for an IND but Are Too Afraid to Ask (60 minutes)

b) Papers:

1. INDs for PET Molecular Imaging Probes (Mol Imaging Biol 2014:16:441)
2. How Should the FDA Review Diagnostic Radiopharmaceuticals? (J Nucl Med 2018; 59:868-870)
3. Perspective on How the FDA Should Review Diagnostic Radiopharmaceuticals (J Nucl Med 2018; 59:865-867)
4. Review FACBC IND and FMISO IND.

1. Fluciclovine (Axumin) training at SNMMI CTN website. Look at DICOM cases. Free course. Registration needed to get certificate. 
2. Readings: Three key papers from FACBC trials: J Urology 2014; 191:1446, Bologna: Eur J Nucl Med Mol Imaging 2016; 43:1601, and European Journal of Radiology 2018; 102:1-8.

1. Read two papers on basic statistics for radiology and power calculations:
   Fundamental Measures of Diagnostic Examination Performance (Radiology 2003; 228:3) and
   Sample Size Estimation: How Many Individuals Should Be Studied? (Radiology 2003; 227:309). 
2. View Stats Overview Presentation.
3. Question and answer session with Dr. Krupinski on statistical principles.
4. Learning lab: a) Interpret 12 known research FACBC cases. b) Fill out table. c) Review patient narratives and compare with standard of truth using rating system. d) Calculate diagnostic performance. e) Compare with expert notes.

Lab module 1 document

1. Finish tasks from Day 3.
2. View presentation: Molecular Image-Guided Targeted Biopsy for Prostate and other Cancer. 
3. Read review paper related to molecular targeted biopsy: Fei at al AJR 2017; 209:255-269.

1. Trace out prostate sample case and targets. Lab module 2 document.
2. Arrange final discussion and question and answers with Dr. Schuster.