Four years into the project, PredictTB is entering a new phase. In 2021, the project hopes to begin preliminary data analyses. Over the next one and a half years, PredictTB’s scientists will look at datasets from the study’s more than 600 participants. Simultaneously, new patients will be recruited for PredictTB’s MRI sub-study. This article provides a look ahead to what 2021 holds for PredictTB.

PredictTB’s overarching goal is to evaluate a set of criteria that identifies which tuberculosis (TB) patients are eligible for shortened treatment. While the current TB standard therapy lasts six months, up to 80% of all TB patients are cured after four months. However, scientists currently do not know beforehand which patients belong to that group. PredictTB looks at a combination of PET/CT scans and bacterial load markers to explore what combination of markers can disclose if a patient is eligible for treatment shortening.

After three years of patient recruitment, the enrollment of new study participants ended late last year. Each of the study’s 600+ participants will be followed up for 18 months after the start of treatment. This means that the majority of PredictTB’s participants either already have completed follow-ups or will do so this year. This in turn means that enough data now has been collected for the project’s scientists to be able to start preliminary data analyses.

PredictTB is a large-scale study with huge datasets, and many teams in the consortium will be involved in analyzing different parts of the data.

The MRI sub-study will compare data from MRI scans and PET/CT scans

Whereas recruitment to PredictTB’s main study was completed last year, a smaller number of patients will still be recruited for the MRI sub-study between February and March of this year.

The MRI sub-study looks at whether information from MRI scans can provide TB scientists with additional information to that which they can receive from PET/CT scans. PET/CT scans are performed on all PredictTB’s patients at baseline, on week four of treatment, and at the end of treatment. In addition to this, the participants in the MRI sub-study will go through an MRI-scan at baseline and on week four.

The small-scale MRI study will not provide scientists with any definitive answers to whether MRI scans can provide TB scientists with insights into how individual patients will respond to treatment. However, it can help scientists understand the potential of future studies on how MRI scans can improve individualized treatment duration for TB patients.

Conclusion

Most patients participating in PredictTB’s study will complete follow-up this year. Only some patients recruited during the second half of 2020 and the patients recruited for the MRI sub-study will complete their follow-up in 2022.

The PredictTB team will have a meeting with the Data Safety Monitoring Board in early April to discuss the data analysis process. The goal is to begin data analyses later this year.