Intraoperative Molecular Imaging with Pafolacianine in Resection of Occult Pulmonary Malignancy in the ELUCIDATE trial.

Abstract

Background: Clinical studies have demonstrated that intraoperative molecular imaging (IMI) with pafolacianine identifies occult pulmonary lesions that are not identified by preoperative CT or by intraoperative inspection techniques in ∼20% of patients. In this study we provide a description of occult lesion clinical data and evaluate characteristics so that surgeons can better incorporate this emerging technology into clinical decision making.

Methods: Participants (n=100) enrolled in a Phase 3 trial of IMI with pafolacianine during pulmonary resection (ELUCIDATE, NCT04241315) were identified. Participants underwent preoperative computed tomography (CT)with 1.25mm slices. Variables and lesion characteristics were analyzed. Positive predictive value and false positive rates were tabulated for IMI fluorescent lesions with predictors of malignant versus benign occult lesions described.

Results: IMI identified 29 occult lesions in 23 (23%) participants. Seventeen of 29 (58%) lesions were identified within the same lobe as known lesions; 12 of 29 (42%) identified in a different lobe from the suspicious nodule known by preoperative assessment. Twenty-three of 29 (79%) of occult lesions found by IMI were resected with an additional wedge resection. Ten of 29 (34%) lesions identified by IMI were malignant. There was no additional morbidity in participants with lesions resected. With pafolacianine, 7 participants had a synchronous primary stage I lung cancer identified and one subject had additional metastases identified. .

Conclusions: IMI with pafolacianine identifies occult malignant lesions during pulmonary resection despite thorough preoperative imaging and intraoperative assessment by experienced surgeons.