Precision Imaging: Quantitative, Molecular, and Image-Guided Technologies One Week Research Rotation and Learning Lab

(Directors: Drs. David Schuster and Baowei Fei)


Objective: Introduction to basics of human translation of a radiotracer.

Day 1:
1) Meet with Assigned Faculty and Clinical Research Staff. Contact Dr. Krupinski (elizabeth.anne.krupinski@emory.edu) to arrange meeting for Wednesday of this week, and Dr. Fei (bfei@emory.edu) to arrange lab visit for Friday of this week. If not possible, arrange another time.
2) Read 2 key papers on fundamentals of translation including FDA/IND and view 3 PowerPoint presentations (may also be completed in advance or after hours). Available on line below.
 
a) Presentations in this order:
Clinical Research in Imaging: Elements for Success (90 min):
http://www.snm.org/video/Clinical_Research_in_Imaging/index.html

Navigating the Regulatory Shoals: Transitioning Your Imaging Agent To The Clinic
  
Everything You Need to Know for an IND but Are Too Afraid to Ask (60 min): http://www.snmmi.org/Video/Player.aspx?VideoID=320
   
b) Papers:
Role of eIND (J Nucl Med 2015; 56:497–500) 
INDs for PET Molecular Imaging Probes (Mol Imaging Biol 2014:16:441)

3) Review FACBC IND and FMISO IND.
 
Day 2:
1) Fluciclovine (Axumin) training at SNMMI CTN website. Look at DICOM cases. Free course. Registration needed to get certificate. 
http://www.snmmi.org/Research/Content.aspx?ItemNumber=10689&navItemNumber=6820

2) Readings: 2 key papers from trials at Emory: J Urology 2014;191:1446 and Bologna: Eur J Nucl Med Mol Imaging 2016;43:1601.


Day 3:
1) Read 2 papers on basic statistics for Radiology and power calculations: Fundamental Measures of Diagnostic Examination Performance (Radiology 2003;228:3) 
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 available here.
 
Day 4:
1) Finish tasks from day 3.
2) View presentation: Molecular Image-guided Targeted Biopsy for Prostate and other Cancer available as PowerPoint with embedded movie.
3) Read key paper related to targeted biopsy. (Urologic Oncology 2014;32:903–911)
4) Trace out prostate sample case and targets. Lab module 2 document available here
 
Day 5:
1) Visit Dr. Fei lab (bfei@emory.edu) to complete modeling and simulate biopsy on a known patient result and compare with actual results. Or if not available, visit another time and use this day to reinforce prior learning.

There may also be an opportunity to see any actual studies being read out or planned during this week or others.