A Clinical Trial of TumorGlow to Identify Residual Disease During Pleurectomy and Decortication.
Aged
Biopsy
Coloring Agents
Feasibility Studies
Female
Follow-Up Studies
Humans
Indocyanine Green
/ pharmacology
Lung Neoplasms
/ diagnosis
Male
Mesothelioma
/ diagnosis
Mesothelioma, Malignant
Microscopy, Fluorescence
/ methods
Middle Aged
Neoplasm, Residual
Pleura
/ pathology
Pleural Neoplasms
/ diagnosis
Retrospective Studies
Thoracic Surgical Procedures
/ methods
Journal
The Annals of thoracic surgery
ISSN: 1552-6259
Titre abrégé: Ann Thorac Surg
Pays: Netherlands
ID NLM: 15030100R
Informations de publication
Date de publication:
01 2019
01 2019
Historique:
received:
23
02
2018
revised:
08
05
2018
accepted:
04
06
2018
pubmed:
22
7
2018
medline:
16
10
2019
entrez:
21
7
2018
Statut:
ppublish
Résumé
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. 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. 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. TumorGlow for malignant pleural mesothelioma is safe and feasible. Excellent sensitivity allows for to reliable detection of macroscopic residual disease during cytoreductive surgical procedures.
Sections du résumé
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.
Identifiants
pubmed: 30028985
pii: S0003-4975(18)30995-0
doi: 10.1016/j.athoracsur.2018.06.015
pmc: PMC6296901
mid: NIHMS1500299
pii:
doi:
Substances chimiques
Coloring Agents
0
Indocyanine Green
IX6J1063HV
Banques de données
ClinicalTrials.gov
['NCT02280954']
Types de publication
Clinical Trial
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
224-232Subventions
Organisme : NCI NIH HHS
ID : R01 CA193556
Pays : United States
Informations de copyright
Copyright © 2019 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
Références
Clin Cancer Res. 2016 Jun 15;22(12):2929-38
pubmed: 27306792
J Thorac Cardiovasc Surg. 2016 Feb;151(2):468-73
pubmed: 26614413
Transl Lung Cancer Res. 2017 Jun;6(3):285-294
pubmed: 28713674
J Clin Oncol. 2009 Jun 20;27(18):3007-13
pubmed: 19364962
Ann Surg. 2017 Sep;266(3):479-488
pubmed: 28746152
Ann Thorac Surg. 2014 Oct;98(4):1223-30
pubmed: 25106680
Crit Rev Oncol Hematol. 2011 May;78(2):92-111
pubmed: 20466560
Neurosurgery. 2016 Dec;79(6):856-871
pubmed: 27741220
J Thorac Cardiovasc Surg. 2008 Mar;135(3):620-6, 626.e1-3
pubmed: 18329481
J Thorac Cardiovasc Surg. 2015 May;149(5):1374-81
pubmed: 25772281
J Clin Oncol. 2003 Jul 15;21(14):2636-44
pubmed: 12860938
J Clin Oncol. 1991 Feb;9(2):313-9
pubmed: 1988578
Am J Nucl Med Mol Imaging. 2015 Jun 15;5(4):390-400
pubmed: 26269776
Lung Cancer. 2005 Jul;49 Suppl 1:S65-8
pubmed: 15916831
Thorac Surg Clin. 2016 Aug;26(3):359-75
pubmed: 27427530
Ann Thorac Surg. 2017 Feb;103(2):390-398
pubmed: 27793401