In Phase I and Phase II studies, dynamic-contrast enhanced magnetic resonance imaging (DCE-MRI) has shown promise in studying the pathophysiology of tumors. We currently measure tumor mass shrinkage to help determine potential efficacy, but DCE-MRI actually allows us to see changes in tumor vascularity by helping to measure blood flow in tissues and provide insight into vascular morphology. And because vascularity occurs at an earlier stage in tumor treatment than does shrinkage, DCE-MRI has the potential to enable earlier assessment of the response or failure of a particular drug. The possibilities here are extremely promising so far.

Regulators are primarily concerned with ensuring that all data is obtained independent from sponsor or imaging CRO bias and with minimal variability. Particularly important is the complete blinding of all clinical data provided to the endpoint assessment committee (EAC). The sponsor must be able to prove that all procedures adhere to pre-defined, study-specific guidelines that address the roles of all participating players (i.e. blinded primary and secondary readers, adjudicators, etc.) and document how exactly the EAC determined and adjudicated the outcome. Clear and explicit procedural directives are crucial. And just as in any other trial, they demand data accrued in compliance with good clinical practices, which means electronic back-up, minimal deviation from instructions, and a transparent audit trail for the entire process.