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. Author manuscript; available in PMC: 2017 Jan 1.
Published in final edited form as: Int J Radiat Oncol Biol Phys. 2015 Sep 30;94(1):189–205. doi: 10.1016/j.ijrobp.2015.09.032

Table 5. Clinical experimental results required for final validation of GNP-enhanced radiotherapy.

Clinical Validation Key Data
Physics Validation Confirmation that anticipated GNP uptake and
distribution will not significantly impact on
radiotherapy planning procedures, or
developing appropriate techniques for planning
GNP-enhanced therapies.
Human biodistribution & toxicity
(Phase 0/1)		 Information on biodistribution and potential
toxicity of GNPs in humans, as well as
clinically feasible dosing and interactions with
other agents (e.g. chemotherapeutics) and
quantification of retention of GNPs inside the
tumor
Human efficacy
(Phase 2/3)		 Validation and quantification of
radiosensitization in patient treatment,
improvements in tumor control and overall
survival