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Assessing a biomarker platform for stratifying indeterminate pulmonary nodules, protocol for the SPOT IT randomized
Rafael Paez1,2, Timothy A Khalil1, Yency Forero1
1Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
Trials
|May 13, 2026
Summary
The SPOT IT trial investigates if a radiomic biomarker improves lung nodule management. This study will clarify the role of the Lung Cancer Prediction score in clinical practice.
Area of Science:
- Radiology and Imaging
- Oncology
- Clinical Trials
Background:
- Millions of lung nodules are detected annually via CT scans.
- Early lung cancer detection is crucial for improving patient survival rates.
- The Lung Cancer Prediction score is a radiomic biomarker for lung nodule risk stratification.
Purpose of the Study:
- To assess if the Lung Cancer Prediction score improves patient management for incidentally detected lung nodules.
- To evaluate the impact of a radiomic biomarker on clinical decision-making in pulmonary nodule evaluation.
Main Methods:
- Multicenter, open-label, randomized controlled superiority trial (SPOT IT).
- Adult patients with 8-30 mm lung nodules randomized 1:1 to usual care plus Lung Cancer Prediction score or usual care alone.
- Primary outcome: appropriate initial nodule management; secondary outcomes: management changes, unnecessary procedures, and time to diagnosis.
Main Results:
- This section will be updated upon study completion as the trial is ongoing.
- The trial aims to provide data on the clinical utility of the Lung Cancer Prediction score.
Conclusions:
- The SPOT IT trial is an ongoing randomized controlled trial evaluating a radiomic prediction score.
- Results may inform clinical practice for pulmonary nodule management and define the biomarker's role.
