Abstract Background Millions of pulmonary nodules are detected every year in the United States. While most are benign, some represent early-stage lung cancer, in which case early detection is crucial to improve survival. The management of indeterminate pulmonary nodules (IPNs) depends on the pretest probability of malignancy and often proves challenging. The Lung Cancer Prediction (LCP) score is a radiomic biomarker developed by Optellum (Optellum LTD, Oxford, UK) to risk-stratify lung nodules. Observational studies have shown promising results, but randomized data are needed to demonstrate improved patient outcomes. We designed SPOT-IT, a multicenter randomized controlled trial to test the hypothesis that a biomarker driven strategy improves patient management compared to usual care. Methods SPOT IT is a multicenter, open label, pragmatic, superiority, randomized controlled trial. Adult patients referred to lung nodule and thoracic surgery clinics with incidentally detected IPNs 8-30mm in size meeting all eligibility criteria are currently being enrolled. Participants are randomized in a 1:1 ratio to receive either usual care combined with the LCP score or usual care alone. Randomization is conducted using permuted blocks of variable size, stratified by study center and nodule size. The primary outcome is “appropriate initial nodule management” defined as the proportion of subjects with benign disease managed with imaging surveillance or with additional diagnostic studies/definite therapy for ultimately malignant nodules. Secondary outcomes include unnecessary invasive procedures for benign nodules, and time to diagnosis for malignant nodules. With a total of 400 randomized patients, the study has 80% power (alpha = 0.5, two-sided) to detect a 15% improvement in the primary outcome measure, allowing for up to 20% dropout rate. The study was approved by the Vanderbilt University Medical Center (single institutional review board) and is being conducted with waiver of consent. The trial was registered in clinicaltrials.gov prior to opening (NCT06638398). Results/Current Status The study opened in October of 2024 with a planned enrollment period through April 2026. A total of 289 patients have been enrolled at the time of this submission. Four sites are actively enrolling with 2 other sites opening in the coming weeks. Discussion SPOT IT is a multicenter randomized controlled trial assessing the clinical impact of a commercially available radiomic biomarker in the management of IPNs. Results from this trial will help clarify the role of this biomarker in routine clinical practice. This abstract is funded by: NCI
Paez et al. (Fri,) studied this question.