Challenges in the Use and Approval of Novel Diagnostic Agents
University Hospital Nijmegen
This course will specifically discuss the challenges in performing clinical trials with novel diagnostic agents with high clinical potential. General guidelines will be given, and skills of the primary investigator required for good outcome will be discussed. More in detail, problems which may arise will be illustrated, using examples of new diagnostic MR agents. In this respect endorectal coil dynamic MRI & MRSI in prostate cancer, USPIO for detection of very small lymph node metastases, and a new oral MN-based liver contrast agent for improved detection of small metastases will be shown.