PET/CT guided tuberculosis treatment shortening: a randomized trial

Area of Science:

• Infectious Diseases
• Radiology
• Medical Imaging

Background:

• Standard treatment for drug-sensitive pulmonary tuberculosis (TB) is six months of chemotherapy.
• Individual patient factors influence the optimal treatment duration for a durable cure.
• Personalizing TB treatment duration can improve outcomes and reduce healthcare costs.

Purpose of the Study:

• To identify factors determining the required length of chemotherapy for durable cure in individual patients with drug-sensitive pulmonary TB.
• To enable individualization of treatment durations and improve clinical tools for new TB regimens.
• To reduce the cost and improve the efficiency of Phase III TB treatment studies.

Main Methods:

• A randomized clinical trial in South Africa and China involving 704 participants with newly diagnosed, drug-sensitive pulmonary TB.
• Participants stratified by FDG PET/CT scan assessment of radiographic disease extent.
• Randomized assignment for less extensive disease to four or six months of therapy; non-randomized arm for more extensive disease.

Main Results:

• Among participants with less extensive disease, four months of therapy resulted in 12.1% unfavorable outcomes versus 1.5% for six months.
• Participants with more extensive disease had only 3.2% unfavorable outcomes.
• Total cavity volume and lesion glycolysis at week 16 predicted unfavorable outcomes; machine learning models showed good performance in predicting relapse.

Conclusions:

• Treatment duration for drug-sensitive pulmonary TB can potentially be shortened for patients with less extensive disease, guided by imaging biomarkers.
• FDG PET/CT imaging and machine learning can predict TB relapse, facilitating personalized treatment strategies.
• These findings support more efficient clinical trials for novel TB treatment regimens.