Proceduralist criteria for evaluating interface utility of novel imaging modalities in early phase clinical trials: evaluating the need for standardized criteria

Eric R. Henderson; Jonathan Elliott; Shudong Jiang; I. Leah Gitajn; John Lee; Summer Gibbs; Michael Bouvet; Anita Mahadevan-Jansen; Michael Daly; Samuel S. Streeter; Keith D. Paulsen; Brian W. Pogue; Kimberley S. Samkoe; Sunil Singhal

doi:10.1117/12.2650756

14 March 2023 Proceduralist criteria for evaluating interface utility of novel imaging modalities in early phase clinical trials: evaluating the need for standardized criteria

Eric R. Henderson, Jonathan Elliott, Shudong Jiang, I. Leah Gitajn, John Lee, Summer Gibbs, Michael Bouvet, Anita Mahadevan-Jansen, Michael Daly, Samuel S. Streeter, Keith D. Paulsen, Brian W. Pogue, Kimberley S. Samkoe, Sunil Singhal

Author Affiliations +

Proceedings Volume 12361, Molecular-Guided Surgery: Molecules, Devices, and Applications IX; 123610F (2023) https://doi.org/10.1117/12.2650756
Event: SPIE BiOS, 2023, San Francisco, California, United States

Abstract

Accelerating innovation in the space of fluorescence imaging for surgical applications has increased interest in safely and expediently advancing these technologies to clinic through Food and Drug Administration- (FDA-) compliant trials. Conventional metrics for early phase trials include drug safety, tolerability, dosing, and pharmacokinetics. Most procedural imaging technologies rely on administration of an exogenous fluorophore and concurrent use of an imaging system; both of which must receive FDA approval to proceed to clinic. Because fluorophores are classified as medical imaging agents, criteria for establishing dose are different, and arguably more complicated, than therapeutic drugs. Since no therapeutic effect is desired, medical imaging agents are ideally administered at the lowest dose that achieves adequate target differentiation. Because procedural imaging modalities are intended to enhance and/or ease proceduralists’ identification or assessment of tissues, beneficial effects of these technologies may manifest in the form of qualitative endpoints such as: 1) confidence; 2) decision-making; and 3) satisfaction with the specified procedure. Due to the rapid expansion of medical imaging technologies, we believe that our field requires standardized criteria to evaluate existing and emerging technologies objectively so that both quantitative and qualitative aspects of their use may be measured and useful comparisons to assess their relative value may occur. Here, we present a 15-item consensus-based survey instrument to assess the utility of novel imaging technologies from the proceduralist’s standpoint.

Conference Presentation

Citation Download Citation

Eric R. Henderson, Jonathan Elliott, Shudong Jiang, I. Leah Gitajn, John Lee, Summer Gibbs, Michael Bouvet, Anita Mahadevan-Jansen, Michael Daly, Samuel S. Streeter, Keith D. Paulsen, Brian W. Pogue, Kimberley S. Samkoe, and Sunil Singhal "Proceduralist criteria for evaluating interface utility of novel imaging modalities in early phase clinical trials: evaluating the need for standardized criteria", Proc. SPIE 12361, Molecular-Guided Surgery: Molecules, Devices, and Applications IX, 123610F (14 March 2023); https://doi.org/10.1117/12.2650756

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