Dataset Information

Preoperative CT versus intraoperative hybrid DynaCT imaging for localization of small pulmonary nodules: a randomized controlled trial.

ABSTRACT: BACKGROUND:Localization of small and/or deep pulmonary nodules before thoracoscopic exploration is paramount to minimize the likelihood of unplanned conversion to thoracotomy. As far as the percutaneous approach is concerned, the most common workflow consists of preoperative computed tomography (POCT) imaging-guided tumor marking (performed in an interventional CT suite) followed by their removal in an operating room (OR). However, the advent of hybrid ORs has allowed intraoperative computed tomography (IOCT)-guided lesion localization. This single center, open-label, randomized, controlled clinical trial aims to compare the efficacy and safety of IOCT versus POCT. METHODS/DESIGN:The study sample will consist of patients presenting with small and/or deep pulmonary nodules who will be randomly allocated to either POCT or IOCT. The time required to complete lesion localization will be the primary efficacy outcome. The following parameters will serve as secondary endpoints: rate of successful targeting during localization and in the operating field, time at risk, operating time, length of time under anesthesia, global OR utilization time, complication (pneumothorax and hemorrhage) rates, and radiation exposure. DISCUSSION:Owing to the increased availability of HORs, our data will be crucial to clarify the feasibility and safety of IOCT versus the traditional POCT approach. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03395964 . Registered on October 8, 2018.

SUBMITTER: Chao YK

PROVIDER: S-EPMC6610996 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Preoperative CT versus intraoperative hybrid DynaCT imaging for localization of small pulmonary nodules: a randomized controlled trial.

Chao Yin-Kai YK Pan Kuang-Tse KT Wen Chih-Tsung CT Fang Hsin-Yueh HY Hsieh Ming-Ju MJ

Trials 20190704 1

<h4>Background</h4>Localization of small and/or deep pulmonary nodules before thoracoscopic exploration is paramount to minimize the likelihood of unplanned conversion to thoracotomy. As far as the percutaneous approach is concerned, the most common workflow consists of preoperative computed tomography (POCT) imaging-guided tumor marking (performed in an interventional CT suite) followed by their removal in an operating room (OR). However, the advent of hybrid ORs has allowed intraoperative comp ...[more]

PMID: 31272483

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Project description:OBJECTIVES:Develop a CT-based radiomics model and combine it with frozen section (FS) and clinical data to distinguish invasive adenocarcinomas (IA) from preinvasive lesions/minimally invasive adenocarcinomas (PM). METHODS:This multicenter study cohort of 623 lung adenocarcinomas was split into training (n?=?331), testing (n?=?143), and external validation dataset (n?=?149). Random forest models were built using selected radiomics features, results from FS, lesion volume, clinical and semantic features, and combinations thereof. The area under the receiver operator characteristic curves (AUC) was used to evaluate model performances. The diagnosis accuracy, calibration, and decision curves of models were tested. RESULTS:The radiomics-based model shows good predictive performance and diagnostic accuracy for distinguishing IA from PM, with AUCs of 0.89, 0.89, and 0.88, in the training, testing, and validation datasets, respectively, and with corresponding accuracies of 0.82, 0.79, and 0.85. Adding lesion volume and FS significantly increases the performance of the model with AUCs of 0.96, 0.97, and 0.96, and with accuracies of 0.91, 0.94, and 0.93 in the three datasets. There is no significant difference in AUC between the FS model enriched with radiomics and volume against an FS model enriched with volume alone, while the former has higher accuracy. The model combining all available information shows minor non-significant improvements in AUC and accuracy compared with an FS model enriched with radiomics and volume. CONCLUSIONS:Radiomics signatures are potential biomarkers for the risk of IA, especially in combination with FS, and could help guide surgical strategy for pulmonary nodules patients. KEY POINTS:• A CT-based radiomics model may be a valuable tool for preoperative prediction of invasive adenocarcinoma for patients with pulmonary nodules. • Radiomics combined with frozen sections could help in guiding surgery strategy for patients with pulmonary nodules.

Project description:Purpose18F-FDG PET/CT is widely used to evaluate indeterminate pulmonary nodules (IPNs). False positive results occur, especially from active granulomatous nodules. A PET-based imaging agent with superior specificity to 18F-FDG for IPNs, is badly needed, especially in areas of endemic granulomatous nodules. Somatostatin receptors (SSTR) are expressed in many malignant cells including small cell and non-small cell lung cancers (NSCLCs). 68Ga-DOTATATE, a positron emitter labeled somatostatin analog, combined with PET/CT imaging, may improve the diagnosis of IPNs over 18F-FDG by reducing false positives. Our study purpose was to test this hypothesis in our region with high endemic granulomatous IPNs.MethodsWe prospectively performed 68Ga-DOTATATE PET/CT and 18F-FDG PET/CT scans in the same 30 patients with newly diagnosed, treatment-naïve lung cancer (N = 14) or IPNs (N = 15) and one metastatic nodule. 68Ga-DOTATATE SUVmax levels at or above 1.5 were considered likely malignant. We analyzed the scan results, correlating with ultimate diagnosis via biopsy or 2-year chest CT follow-up. We also correlated 68Ga-DOTATATE uptake with immunohistochemical (IHC) staining for SSTR subtype 2A (SSTR2A) in pathological specimens.ResultsWe analyzed 31 lesions in 30 individuals, with 14 (45%) being non-neuroendocrine lung cancers and 1 (3%) being metastatic disease. McNemar's result comparing the two radiopharmaceuticals (p = 0.65) indicates that their accuracy of diagnosis in this indication are equivalent. 68Ga-DOTATATE was more specific (94% compared to 81%) and less sensitive 73% compared to 93%) than 18F-FDG. 68Ga-DOTATATE uptake correlated with SSTR2A expression in tumor stroma determined by immunohistochemical (IHC) staining in 5 of 9 (55%) NSCLCs.Conclusion68Ga-DOTATATE and 18F-FDG PET/CT had equivalent accuracy in the diagnosis of non-neuroendocrine lung cancer and 68Ga-DOTATATE was more specific than 18F-FDG for the diagnosis of IPNs. IHC staining for SSTR2A receptor expression correlated with tumor stroma but not tumor cells.

Project description:BackgroundPreoperative computed tomography (CT)-guided localization of small pulmonary nodules (SPNs) is the major approach for accurate intraoperative visualization in video-assisted thoracoscopic surgery (VATS). However, this interventional procedure has certain risks and may challenge to less experienced junior doctors. This study aims to evaluate the feasibility and efficacy of robotic-assisted CT-guided preoperative pulmonary nodules localization with the modified hook-wire needles before VATS.MethodsA total of 599 patients with 654 SPNs who preoperatively accepted robotic-assisted CT-guided percutaneous pulmonary localization were respectively enrolled and compared to 90 patients with 94 SPNs who underwent the conventional CT-guided manual localization. The clinical and imaging data including patients' basic information, pulmonary nodule features, location procedure findings, and operation time were analyzed.ResultsThe localization success rate was 96.64% (632/654). The mean time required for marking was 22.85±10.27 min. Anchor of dislodgement occurred in 2 cases (0.31%). Localization-related complications included pneumothorax in 163 cases (27.21%), parenchymal hemorrhage in 222 cases (33.94%), pleural reaction in 3 cases (0.50%), and intercostal vascular hemorrhage in 5 cases (0.83%). Localization and VATS were performed within 24 hours. All devices were successfully retrieved in VATS. Histopathological examination revealed 166 (25.38%) benign nodules and 488 (74.62%) malignant nodules. For patients who received localizations, VATS spent a significantly shorter time, especially the segmentectomy group (93.61±35.72 vs. 167.50±40.70 min, P<0.001). The proportion of pneumothorax in the robotic-assisted group significantly decreased compared with the conventional manual group (27.21% vs. 43.33%, P=0.002).ConclusionsRobotic-assisted CT-guided percutaneous pulmonary nodules hook-wire localization could be effectively helpful for junior less experienced interventional physicians to master the procedure and potentially increase precision.

Dataset Information

Preoperative CT versus intraoperative hybrid DynaCT imaging for localization of small pulmonary nodules: a randomized controlled trial.

Publications

Preoperative CT versus intraoperative hybrid DynaCT imaging for localization of small pulmonary nodules: a randomized controlled trial.

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