Does PET-CT Have a Role in the Evaluation of Tuberculosis Treatment in Phase 2 Clinical Trials?

Positron emission tomography-computed tomography (PET-CT) has the potential to revolutionize research in infectious diseases, as it has done with cancer. There is growing interest in it as a biomarker in the setting of early-phase tuberculosis clinical trials, particularly given the limitations of current biomarkers as adequate predictors of sterilizing cure for tuberculosis. PET-CT is a real-time tool that provides a 3-dimensional view of the spatial distribution of tuberculosis within the lung parenchyma and the nature of lesions with uptake (ie, whether nodular, consolidative, or cavitary). Its ability to provide functional data on changes in metabolism, drug penetration, and immune control of tuberculous lesions has the potential to facilitate drug development and regimen selection for advancement to phase 3 trials in tuberculosis. In this narrative review, we discuss the role that PET-CT may have in evaluating responses to drug therapy in active tuberculosis treatment and the challenges in taking PET-CT forward as predictive biomarker of relapse-free cure in the setting of phase 2 clinical trials. There is mounting use of PET-CT as a biomarker of tuberculosis treatment. In this review, we explore the evidence available to date and what remains to support its use in early-phase clinical tuberculosis trials.

Automated summary

PET-CT has the potential to revolutionize research in infectious diseases, particularly in tuberculosis clinical trials. It provides real-time information about the spatial distribution and nature of tuberculosis lesions in the lungs, which can aid in drug development and regimen selection. However, there are challenges in using PET-CT as a predictive biomarker of relapse-free cure in phase 2 clinical trials.