The following is a summary of “Pafolacianine for intraoperative molecular imaging of cancer in the lung: The ELUCIDATE trial,” published in the December 2023 issue of Surgery by Sarkaria, et al.
Pafolacianine is a folate receptor–targeted fluorescent agent. For a study, researchers sought to determine the clinical utility of this agent in revealing folate receptor-positive cancers in the lung and narrow surgical margins through intraoperative molecular imaging. These cancers may otherwise go undetected through conventional visualization methods.
112 patients with suspected or biopsy-confirmed lung cancer who were scheduled to undergo sub-lobar pulmonary resection were given intravenous pafolacianine beginning 24 hours before surgery as part of this Phase 3 study that was conducted at twelve different centers. Random assignment was used to determine whether the participants would have surgery with or without intraoperative molecular imaging (10:1 ratio).
The percentage of individuals who had a clinically significant event that reflected a meaningful change in the surgical procedure was the main end goal that was measured using this method. There were no major adverse events that were associated with the medicine. Five-thirds of the patients examined had at least one clinically important incident, significantly more than the predetermined threshold of 10% (P <.0001). At least one incident occurred within a margin of 10 millimeters or less from the original nodule removed from 38 patients (38%, 95% CI, 28.5-48.3), with 32 of these events being verified by histology. With intraoperative molecular imaging, the main nodule that the surgeon could not find via white light and palpation was discovered in 19 of the participants, which made up 19% of the 95% CI.
Using white light, intraoperative molecular imaging identified ten occult synchronous malignant lesions in eight participants (8%, 95% CI, 3.5-15.2) that were not detected. 73% of the synchronous malignant lesions found using intraoperative molecular imaging were located outside of the targeted resection region. 29 of the individuals saw a change in the total scope of the surgical treatment, with 22 of them seeing an increase and 7 experiencing a reduction. Surgical outcomes may be improved with the use of intraoperative molecular imaging using pafolacianine. This is accomplished by finding occult cancers and closing surgical margins.
Source: sciencedirect.com/science/article/abs/pii/S002252232300185X