The Journal of Thoracic and Cardiovascular Surgery
Thoracic: Lung Cancer: Clinical Trial: Evolving TechnologyPafolacianine for intraoperative molecular imaging of cancer in the lung: The ELUCIDATE trial
Graphical abstract
Methods, results, and implications are presented in a single graphical abstract.
Section snippets
Trial Design and Oversight
Before surgery, participants were randomized to undergo white light plus IMI or white light only (10:1 ratio, as requested by the Food and Drug Administration). The assignment for imaging was revealed during surgery but only after completion of the white light evaluation and before IMI. The purpose of the 10:1 nonstratified permuted block randomization was only to reduce the risk of potential bias from underestimating the number of lesions localized first with white light if knowing that NIR
Characteristics of the Participants
The Consolidated Standards of Reporting Trials flow diagram is presented in Figure 3. Among 140 patients screened for eligibility, 24 were screen failures and 4 of the remaining 116 randomized participants were discontinued during the screening period before receiving an infusion of the study drug, and 1 additional participant withdrew consent because of an infusion reaction. Demographic characteristics of participants in the FS (N = 112), which includes the 1 participant who received the
Discussion
Pafolacianine represents a first-in-class agent to aid the surgeon in visualizing otherwise undetectable tumors and in determining tumor to resection margin distance.20,22 It offers the possibility of improving outcomes of cancer surgery by enabling surgeons to better identify primary tumors, detect occult synchronous lesions, and ensure adequate margins of resection. The technology is adjunctive to, rather than a replacement for, current preoperative imaging and intraoperative clinical
Conclusions
The use of IMI with pafolacianine represents a significant potential advancement over white light visualization alone by enhancing the intraoperative localization of presumed cancerous nodules, improving the ability to remove them with clean margins, and reducing the probability of leaving malignant tissue behind.
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The ELUCIDATE Study Group: Michael I. Ebright, MD, Columbia University Medical Center; Sidharta Peña Gangadharan, MD, Beth Israel Deaconess Medical Center; Brian E. Louie, MD, Swedish Cancer Institute and Medical Center; Sudish C. Murthy, MD, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University; Kalpaj R. Parekh, MBBS, University of Iowa Carver College of Medicine; Rishindra M. Reddy, MD, University of Michigan Medical School; Benny Weksler, MD, Allegheny General Hospital.
Funding for this study was provided by On Target Laboratories, Inc.
Advarra Institutional Review Board approval November 25, 2019, #Pro00040361.