Biomarker Platform (Virtual Nodule Clinic) for the Management of Indeterminate Pulmonary Nodules

Description

PRIMARY OBJECTIVES:

I. To test the hypothesis that usual care plus a radiomic prediction score impacts patient management compared to usual care alone.

II. To conduct a multicenter pragmatic randomized controlled platform trial using a validated biomarker, the radiomic prediction score.

III. To conduct a biomarker study that will evaluate the first necessary (but not sufficient) step to show clinical utility.

IV. To assess the magnitude of change in patient management with use of the radiomic prediction score.

V. To develop a platform that can be used as framework for future larger biomarker studies.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo standard of care (SOC) computed tomography (CT) evaluation and receive a Virtual Nodule Clinic radiomic prediction score on study. Patients then receive SOC lung nodule management on study.

ARM II: Patients undergo SOC CT evaluation on study. Patients then receive SOC lung nodule management on study.