A Clinical Trial of TumorGlow to Identify Residual Disease During Pleurectomy and Decortication.

Authors

• Jarrod D Predina
• Andrew D Newton
• Christopher Corbett
• Leilei Xia
• Michael Shin
• Lydia Frenzel Sulfyok
• Olugbenga T Okusanya
• Keith A Cengel
• Andrew Haas
• Leslie Litzky
• John C Kucharczuk
• Sunil Singhal

Publication/Presentation Date

1-1-2019

Abstract

BACKGROUND: Macroscopic complete resection can improve survival in a select group of patients with malignant pleural mesothelioma. During resection, differentiating residual tumor from inflammation or scar can be challenging. This trial evaluated near-infrared (NIR) intraoperative imaging using TumorGlow (a novel NIR imaging approach utilizing high-dose indocyanine green and delayed imaging) technology to improve detection of macroscopic residual disease.

METHODS: Twenty subjects were enrolled in an open-label clinical trial of NIR intraoperative imaging with TumorGlow (Indocyanine Green for Solid Tumors [NCT02280954]). Twenty-four hours before pleural biopsy or pleurectomy and decortication (P/D), patients received intravenous indocyanine green. All specimens identified during standard-of-care surgical resection and with NIR imaging underwent histopathologic profiling and correlative microscopic fluorescent tomographic evaluation. For subjects undergoing P/D (n = 13), the hemithorax was evaluated with NIR imaging during P/D to assess for residual disease. When possible, additional fluorescent lesions were resected.

RESULTS: Of 203 resected specimens submitted for evaluation, indocyanine green accumulated within 113 of 113 of resected mesothelioma specimens, with a mean signal-to-background fluorescence ratio of 3.1 (SD, 2.2 to 4.8). The mean signal-to-background fluorescence ratio of benign tissues was 2.2 (SD, 1.4 to 2.4), which was significantly lower than in malignant specimens (p = 0.001). NIR imaging identified occult macroscopic residual disease in 10 of 13 subjects. A median of 5.6 resectable residual deposits per patient (range, 0 to 11 deposits per patient), with a mean size of 0.3 cm (range, 0.1 to 1.5 cm), were identified.

CONCLUSIONS: TumorGlow for malignant pleural mesothelioma is safe and feasible. Excellent sensitivity allows for to reliable detection of macroscopic residual disease during cytoreductive surgical procedures.

Volume

107

Issue

1

First Page

224

Last Page

232

ISSN

1552-6259

Published In/Presented At

Predina, J. D., Newton, A. D., Corbett, C., Xia, L., Shin, M., Sulfyok, L. F., Okusanya, O. T., Cengel, K. A., Haas, A., Litzky, L., Kucharczuk, J. C., & Singhal, S. (2019). A Clinical Trial of TumorGlow to Identify Residual Disease During Pleurectomy and Decortication. The Annals of thoracic surgery, 107(1), 224–232. https://doi.org/10.1016/j.athoracsur.2018.06.015

Disciplines

Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods

PubMedID

30028985

Department(s)

Administration and Leadership

Document Type

Article