Beyond Correlations, Sensitivities, and Specificities

Abstract

Although advanced imaging is an important component of oncology clinical trials, there has not been a lot of success in advancing its use from a research perspective. One likely reason is the lack of consensus on the methodology used to study advanced imaging in trials, which results in a disconcerted research effort and produces data that are difficult to collate for use in validating the imaging components being studied. Imaging is used in cancer clinical trials for various indications, and the study design needed to evaluate the imaging in a particular indication will vary. Through case examples, this paper will discuss how advanced imaging is currently being investigated in oncology clinical trials, categorized by the potential clinical indication for the imaging tool and offer suggestions on how development should proceed to further evaluate imaging in the given indication. Available NCI resources which can assist in this process will also be discussed.

SPECT/CT imaging of chemotherapy-induced tumor apoptosis using 99mTc-labeled dendrimer-entrapped gold nanoparticles

“…This makes current conventional imaging techniques limited and insufficient in the early evaluation of its therapeutic effects (Goffin et al., 2005 ). Molecular imaging techniques such as positron emission tomography (PET) and single photon emission computed tomography (SPECT), based on noninvasive imaging of tumor physiology and metabolism that precede apparent morphologic changes, can provide sensitive and specific approaches for monitoring early treatment in oncology (Brindle, 2008 ; Garin et al., 2012 ; Vaidya et al., 2012 ; Lin et al., 2017 ; Zhao et al., 2017 ). Furthermore, these molecular imaging modalities can be integrated with CT or MR to compensate for the lack of anatomical information, leading to more precise evaluation (Delbeke et al., 2009 ; Kao et al., 2012 ; Palmedo et al., 2014 ; Koh et al., 2016 ).…”

Harnessing imaging tools to guide immunotherapy trials: summary from the National Cancer Institute Cancer Imaging Steering Committee workshop

“…The designs of clinical trials for the assessment of these roles are distinct and NCI clinical trial consortia, among others, offer a conduit for these important investigations. 70,71 Funding opportunities are available through various mechanisms in the National Institutes of Health (NIH) to support such discoveries and development. [72][73][74] Overall, there is considerable interest in and support for activities in current and planned immunotherapy trials that use diagnostic imaging for both predictive capabilities and response assessment.…”