CHALLENGES IN MEASURING RESPONSE IN Sample Clauses

CHALLENGES IN MEASURING RESPONSE IN. RETINOBLASTOMA There are several challenges to objectively measuring tumour response in retinoblastoma, and no previous retinoblastoma trial has described tumour responses quantitatively. There are several reasons for this limitation. First, there is no single objective method to measure tumour dimensions due to the complexity of multiple tumours in both eyes and largely subjective “expert” interpretation of “active” vs “quiescent” tumour mass vs scar remnant. Second, retinoblastoma target lesions can include the primary tumour(s) and vitreous/subretinal seeds. Third, there are no established criteria for retinoblastoma that describe the response of the entire eye inclusive of all target lesions and seeds. Unlike most other solid tumours that can only be visualized by radiologic imaging with no estimate of “viable” disease, viable vs non-viable areas of retinoblastoma tumours are judged when directly visualized by the treating ophthalmologist during EUAs and captured with photography, optical coherence tomography (OCT)40 and best summarized in the standard retinal drawing. Since the 1950s innovation of the indirect ophthalmoscope facilitated a wide field of view of the whole retina, the standardized retinal drawing with an internationally endorsed color code (for example, active retinoblastoma is drawn in yellow) has been a key part of management of retinoblastoma. In this clinical trial we will use standard of care consensus of the care team, to evaluate tumour activity at various time points. STEP-RB Protocol 1.0, 4 February 2020
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