Clinical testing of drug treatment shortening in patients with TB using PET/CT imaging of lung lesions

Six months of drug treatment is standard of care for drug-sensitive pulmonary tuberculosis (TB). Understanding the factors determining the length of treatment required for durable cure would allow individualization of treatment durations. We conducted a prospective, randomized, controlled noninferiority trial (PredictTB) of 4 versus 6 months of chemotherapy in patients with pulmonary TB in South Africa and China. Seven hundred and four participants with newly diagnosed, drug-sensitive TB were enrolled and stratified on the basis of radiographic disease characteristics assessed by FDG PET/CT imaging. Participants with less extensive disease (<i>n</i> = 273) were randomly assigned at week 16 to complete therapy after 4 months or continue receiving treatment for 6 months. This study was stopped early after an interim analysis revealed that patients assigned to the 4-month treatment arm had a higher risk of relapse. Among participants who received 4 months of chemotherapy, 17 of 141 (12.1%) experienced TB-specific unfavorable outcomes compared with only 2 of 132 (1.5%) who completed 6 months of treatment. In the nonrandomized arm that included participants with more extensive disease, only 8 of 248 (3.2%) experienced unfavorable outcomes. Total lung cavity volume and lesion glycolysis at week 16 were associated with the risk of unfavorable outcomes. PET/CT imaging at TB recurrence showed that bacteriological relapses predominantly occurred in active cavities originally present at baseline. Subsequent post hoc automated segmentation of serial PET/CT scans combined with machine learning enabled the classification of participants according to their likelihood of relapse.

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Publication Details

Journal
Science Translational Medicine
Published
2026-01-07
DOI
https://doi.org/10.1126/scitranslmed.adt5626
Citations
1
Primary Topic
Tuberculosis Research and Epidemiology
Type
article
Field-Weighted Citation Impact
32.78
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article

Clinical testing of drug treatment shortening in patients with TB using PET/CT imaging of lung lesions

Richard Court, Stephanus T. Malherbe, Lisa J. White, Laura E. Via et al.
1 citations
Science Translational Medicine
Tuberculosis Research and Epidemiology
32.78
article

Clinical testing of drug treatment shortening in patients with TB using PET/CT imaging of lung lesions

Richard Court, Stephanus T. Malherbe, Lisa J. White, Laura E. Via, Michael Harris, Kim Narunsky, Bronwyn Smith, Lori E. Dodd, Praveen Paripati, Gerhard Walzl, R Dawson, Andreas H. Diacon, Friedrich Thienemann, Derek T. Armstrong, Joel Vincent, Remy Daroowala, Simon C. Mendelsohn, R Wilkinson, Michèle Tameris, Aurelie Gouel, Michael Duvenhage, Jill Winter, Yahong Qu, Kriti Arora, Rene T. Goliath, Petri Ahlers, Lisa C. Goldfeder, Kurt Wollenberg, Saalikha Aziz, Ray Chen, Gita Khalili Moghaddam, Sandra Mukasa, Saher Lahouar, Brendan M. Jeffrey, Keboile Serole, Arshad Taliep, Xiang Yu, Hongjian Jin, Mike Tartakovsky, Laylah Da Costa, Shouguo Pan, Dr Bianca Sossen, Q. Gao, Clifton E Barry, Taeksun Song, Hongfei Duan, Hong Zhu, Xin Liu, Lili Liang, Jing Wang, Chuen-Yen Lau, Alex Rosenthal, Ying Cai, Jingcai Gao, Samy Hassan
article en
1 citations

Abstract

Six months of drug treatment is standard of care for drug-sensitive pulmonary tuberculosis (TB). Understanding the factors determining the length of treatment required for durable cure would allow individualization of treatment durations. We conducted a prospective, randomized, controlled noninferiority trial (PredictTB) of 4 versus 6 months of chemotherapy in patients with pulmonary TB in South Africa and China. Seven hundred and four participants with newly diagnosed, drug-sensitive TB were enrolled and stratified on the basis of radiographic disease characteristics assessed by FDG PET/CT imaging. Participants with less extensive disease (<i>n</i> = 273) were randomly assigned at week 16 to complete therapy after 4 months or continue receiving treatment for 6 months. This study was stopped early after an interim analysis revealed that patients assigned to the 4-month treatment arm had a higher risk of relapse. Among participants who received 4 months of chemotherapy, 17 of 141 (12.1%) experienced TB-specific unfavorable outcomes compared with only 2 of 132 (1.5%) who completed 6 months of treatment. In the nonrandomized arm that included participants with more extensive disease, only 8 of 248 (3.2%) experienced unfavorable outcomes. Total lung cavity volume and lesion glycolysis at week 16 were associated with the risk of unfavorable outcomes. PET/CT imaging at TB recurrence showed that bacteriological relapses predominantly occurred in active cavities originally present at baseline. Subsequent post hoc automated segmentation of serial PET/CT scans combined with machine learning enabled the classification of participants according to their likelihood of relapse.

Science Translational MedicineVol. 18(831)
South African Medical Research Council (ZA), National Institutes of Health (US), Shanghai Medical College of Fudan University (CN), Johns Hopkins University (US), University of Cape Town (ZA), University of Zurich (CH), University of Cambridge (GB), The Francis Crick Institute (GB), Task Applied Science (ZA), Office of the Director (US), Xinjiang Uygur Autonomous Region Disease Prevention and Control Center (CN), Kaifeng University (CN), University Hospital of Zurich (CH), Beijing Chest Hospital (CN), South African Tuberculosis Vaccine Initiative (ZA), South African Radio Astronomy Observatory (ZA), Frederick National Laboratory for Cancer Research (US), National Institute of Allergy and Infectious Diseases (US), Office of the Director (US), Wellcome Centre for Infectious Diseases Research in Africa (ZA), Catalysis Foundation for Health (US), Henan Provincial Chest Hospital (CN), Garrett Technologies (United States) (US), Henan Provincial Center for Disease Control and Prevention (CN), JNCL-NCLIS (US), Imperial College London (GB)
Good health and well-being
Openalex Percentile: Top 2%
Tuberculosis Research and Epidemiology
32.78
DOIOpen Access PDFOpenAlex
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