Beyond Correlations, Sensitivities, and Specificities: Case Examples of the Evaluation of Advanced Imaging in Oncology Clinical Trials and Cancer Treatment

Acad Radiol. 2017 Aug;24(8):1027-1035. doi: 10.1016/j.acra.2016.11.024. Epub 2017 Apr 11.


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 National Cancer Institute resources that can assist in this process will also be discussed.

Keywords: Clinical trial; cancer imaging; study design.

Publication types

  • Review

MeSH terms

  • Biomarkers, Tumor
  • Clinical Trials as Topic
  • Diagnostic Imaging / methods*
  • Endpoint Determination
  • Humans
  • Neoplasm Staging
  • Neoplasms / diagnostic imaging*
  • Neoplasms / pathology
  • Neoplasms / therapy
  • Prognosis
  • Research Design*


  • Biomarkers, Tumor