Phase 2 Clinical Trial of VGT-309 for Intraoperative Molecular Imaging During Pulmonary Resection.

Autor:	Bou-Samra P; Department of Surgery, The University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania; Division of Thoracic Surgery, Department of Surgery, University of Pennsylvania Perelman School of Medicine Philadelphia, Pennsylvania., Kennedy GT; Department of Surgery, The University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania; Division of Thoracic Surgery, Department of Surgery, University of Pennsylvania Perelman School of Medicine Philadelphia, Pennsylvania., Chang A; Department of Surgery, The University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania; Division of Thoracic Surgery, Department of Surgery, University of Pennsylvania Perelman School of Medicine Philadelphia, Pennsylvania., Guo E; Department of Surgery, The University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania; Division of Thoracic Surgery, Department of Surgery, University of Pennsylvania Perelman School of Medicine Philadelphia, Pennsylvania., Azari FS; Department of Surgery, The University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania; Division of Thoracic Surgery, Department of Surgery, University of Pennsylvania Perelman School of Medicine Philadelphia, Pennsylvania., Din A; Department of Surgery, The University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania; Division of Thoracic Surgery, Department of Surgery, University of Pennsylvania Perelman School of Medicine Philadelphia, Pennsylvania., Santini JT Jr; Vergent Bioscience, Minneapolis, Minnesota., Bensen ES; Vergent Bioscience, Minneapolis, Minnesota., Singhal S; Department of Surgery, The University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania; Division of Thoracic Surgery, Department of Surgery, University of Pennsylvania Perelman School of Medicine Philadelphia, Pennsylvania. Electronic address: sunil.singhal@pennmedicine.upenn.edu.
Jazyk:	angličtina
Zdroj:	The Annals of thoracic surgery [Ann Thorac Surg] 2024 May 31. Date of Electronic Publication: 2024 May 31.
DOI:	10.1016/j.athoracsur.2024.05.019
Abstrakt:	Background: Advances in intraoperative molecular imaging (IMI) may improve surgical outcomes when resecting tumors in the lung. A single-center trial was conducted using VGT-309, a cathepsin-targeted near-infrared imaging agent that causes lung nodules to fluoresce during surgical resection. The end point of this phase 2 study was to evaluate the frequency that IMI with VGT-309 resulted in a clinically significant event (CSE): localization of pulmonary nodules, discovery of unsuspected additional cancers, or identification of positive margins. Methods: Patients undergoing surgical resection for known or suspected cancer in the lung received VGT-309 (0.32 mg/kg) preoperatively. During the surgical procedure, localization and resection of the nodules were performed using standard surgical techniques. Near-infrared imaging was then used to localize nodules, seek occult lesions, and assess resection margins. Efficacy was measured by the frequency of CSEs. Results: Of the 40 patients who underwent pulmonary resection with VGT-309, 17 (42.5%) had at least 1 CSE. Near-infrared imaging identified lesions not found by standard surgical methods in 16 patients, additional cancers not found by preoperative imaging in 1 patient, and margins within 5 mm of the closest staple line in 2 patients. VGT-309 performance was tested across a broad range of tumor types and commercial near-infrared imaging systems. VGT-309 appeared safe, well-tolerated, with no infusion reactions, and no drug-related serious adverse events. Conclusions: This phase 2 study demonstrated the utility of IMI with VGT-309 in localizing pulmonary nodules, recognizing synchronous lesions, and identifying positive margins. A multi-institutional study will further evaluate the efficacy of VGT-309. Competing Interests: Disclosures Patrick Bou-Samra reports financial support was provided by Vergent Bioscience. Eric S. Bensen reports a relationship with Vergent Bioscience that includes: employment, equity or stocks, nonfinancial support, and travel reimbursement John T. Santini reports a relationship with Vergent Bioscience that includes: employment, equity or stocks, nonfinancial support, and travel reimbursement. The other authors have no conflicts of interest to disclose. (Copyright © 2024 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu