TABLE 2

Summary of Recommendations

Recommendation	Summary
1	• Microdosing can be used to confirm target specificity but is insufficient for intraoperative imaging.
2	• It is currently unclear if the device and the drug product should be paired or general parameters for devices set for each drug product. Discussions during a pre-IND meeting or during a subsequent meeting with FDA (such an end of phase 2 meeting) should address combination product development considerations. However, it is preferable for device manufacturers to seek marketing approval without restriction of the device to any specific optical imaging agent if the device can successfully image more than 1 fluorophore within the device’s excitation/emission spectrum.
3	• Dose- and time-ranging studies should be performed in phase I clinical trial setting. A dose-escalation study designed to detect optimal imaging contrast during surgery as well as safety is generally preferred over a trial design or dosing schedule intended solely to assess imaging agent safety.
4	• Considering the multiple indications optical imaging agents may ultimately be approved for, the common verification for a cancer indication should be demonstration that the imaging successfully delineates normal from abnormal tissue. There is a consensus that a standard methodology should be introduced to accomplish the correlation of fluorescence with the presence of tumor.
5	• The general consensus is that in order for optically guided surgery to advance to routine clinical use, there must be a widely adopted methodology for fluorescence assessment. This degree of standardized and objective assessment will be helpful for regulatory approval to critically demonstrate the ability of the technique to provide disease-specific contrast.
6	• Acceptable toxicity for optical contrast agents for oncologic surgery should be between diagnostic and therapeutic agents.
7	• Grade 2 toxicity in 20% of the population is an acceptable threshold as a dose limiting toxicity.