Mobile 3D C-arm CT for Lung Tumor Localization Efficacy Analysis: a Prospective Clinical Trial
NCT ID: NCT04974632
Last Updated: 2025-02-26
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
41 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-07-01
Study Completion Date
2022-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
It is well known that video-assisted thoracoscopic surgery (VATS) is preferred to open surgery for lung resection because of the smaller incisions and optimized postoperative recovery, including a shorter length of hospitalization and much decreased local tenderness. Studies have shown less operative and post-operative morbidity with decreased operative times. However, for small nodules (i.e. lesions \<1 cm or those at a distance more than 1.5cm from the lung periphery), adequate identification of the target nodule has been being difficult by VATS with necessity of more significant resection or thoracotomy conversion to ensure complete tumor resection.
In order to improve nodule localization, a variety of preoperative localization methods such as CT-guide hook wire or methyl blue dye localization have been proposed. It has been proved to be much easier to mark lung nodules and help guide resection during VATS. However, there are certain concerns. First, it is difficult to minimize the time between the localization procedure and the subsequent surgery in reality. Second, there is concern for patient safety, in particular pneumothorax or hemothorax, during transferred to and from the ward to the radiology suit and in the frequent delays and waiting in reception areas prior to transfer to operating theaters. Finally, interdepartmental transfers and delays can also increase the risk of hook wire dislodgement.
Theoretically, the aforementioned disadvantage could be solved by performing the localization procedure and the lung surgery in the same operating room environment. We performed single-step localization and removal of small pulmonary nodules in the hybrid OR equipped with floor-mounted C-arm cone-beam computed tomography (CBCT) in the previous study. However, it costed a lot of money and every localization could only be performed in the hybrid OR. Mobile 3D C-arm CT is another form of CBCT. It depicts soft tissues with high contrast but also offer a more affordable solution with relative low cost. In this case series, we will investigate the use of a mobile 3D C-arm CT for single-step localization and removal of small pulmonary nodules.
In order to improve nodule localization, a variety of preoperative localization methods such as CT-guide hook wire or methyl blue dye localization have been proposed. It has been proved to be much easier to mark lung nodules and help guide resection during VATS. However, there are certain concerns. First, it is difficult to minimize the time between the localization procedure and the subsequent surgery in reality. Second, there is concern for patient safety, in particular pneumothorax or hemothorax, during transferred to and from the ward to the radiology suit and in the frequent delays and waiting in reception areas prior to transfer to operating theaters. Finally, interdepartmental transfers and delays can also increase the risk of hook wire dislodgement.
Theoretically, the aforementioned disadvantage could be solved by performing the localization procedure and the lung surgery in the same operating room environment. We performed single-step localization and removal of small pulmonary nodules in the hybrid OR equipped with floor-mounted C-arm cone-beam computed tomography (CBCT) in the previous study. However, it costed a lot of money and every localization could only be performed in the hybrid OR. Mobile 3D C-arm CT is another form of CBCT. It depicts soft tissues with high contrast but also offer a more affordable solution with relative low cost. In this case series, we will investigate the use of a mobile 3D C-arm CT for single-step localization and removal of small pulmonary nodules.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Preoperative CT Scan Guided and Intraoperative Hybrid DynaCT Scan-Guided Small Lung Tumor Localization
NCT03395964
Small and/or Deep Lung Tumor
COMPLETED
NA
Partial Pressure of Oxygen Control Method in Identification of Intersegmental Plane
NCT06644066
Lung Cancer
RECRUITING
NA
Localization for Deep Lung Nodules: Microcoil Versus Contrast Injection
NCT03617029
Lung Cancer
UNKNOWN
NA
The Accuracy of Targeted Lymph Node Dissection of Non-small Cell Lung Cancer Patients According to Predictive Models
NCT06768853
Non-small Cell Lung Cancer
NOT_YET_RECRUITING
NA
Augmented Reality-assisted Localization of Solitary Pulmonary Nodules for Precise Sublobar Lung Resection
NCT05162235
SPN
Lung Cancer
UNKNOWN
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Pre-operative CT scans will be used for localization planning. The images will be reviewed by our team to determine optimal placement of wires or indocyanine green. After induction of general anesthesia and insertion of a double-lumen tube, the patient will be placed in either supine, prone or lateral decubitus position. Under end-inspiratory breath-hold, an initial 30 second rotary scan for surgical planning will be obtained. The puncture path will be planned to be as short as possible while avoiding transfissural punctures or being oriented towards major vascular structure. The skin entry site for the planned needle puncture route will then identified under the guidance of the referential metallic marker. An 18-gauze marker needle will be gradually advanced under CT-guidance until it reached the target lesion. A total of 0.3 ml ICG dye(for superficial lesion) or microcoil or hookwire(for deeper lesion) will then be used to localize the tumor.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Lung Tumor
Thoracoscopic Surgery
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
localization
small, deep or ground-glass opacity (GGO) lung tumor, Mobile 3D C-arm CT assisted pre-operative localization, video-assisted thoracic surgery(VATS)
Group Type
OTHER
localization
Intervention Type
PROCEDURE
small, deep or ground-glass opacity (GGO) lung tumor, Mobile 3D C-arm CT assisted pre-operative localization, video-assisted thoracic surgery(VATS)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
localization
small, deep or ground-glass opacity (GGO) lung tumor, Mobile 3D C-arm CT assisted pre-operative localization, video-assisted thoracic surgery(VATS)
Intervention Type
PROCEDURE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
\<1 cm, those at a distance more than 1.5 cm from the lung periphery, or ground-glass opacity (GGO) lung lesion.
Exclusion Criteria
Age \<20 serious pulmonary heart disease more than one tumors needed localization
Minimum Eligible Age
20 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chang Gung Memorial Hospital
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yin-Kai Chao, MD, Ph D
Role: STUDY_CHAIR
Chang Gung Memorial Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Taiwan
References
Explore related publications, articles, or registry entries linked to this study.
Wang BY, Huang JY, Cheng CY, Lin CH, Ko J, Liaw YP. Lung cancer and prognosis in taiwan: a population-based cancer registry. J Thorac Oncol. 2013 Sep;8(9):1128-35. doi: 10.1097/JTO.0b013e31829ceba4.
Reference Type
BACKGROUND
Huang HL, Kung PT, Chiu CF, Wang YH, Tsai WC. Factors associated with lung cancer patients refusing treatment and their survival: a national cohort study under a universal health insurance in Taiwan. PLoS One. 2014 Jul 7;9(7):e101731. doi: 10.1371/journal.pone.0101731. eCollection 2014.
Reference Type
BACKGROUND
Bach PB, Mirkin JN, Oliver TK, Azzoli CG, Berry DA, Brawley OW, Byers T, Colditz GA, Gould MK, Jett JR, Sabichi AL, Smith-Bindman R, Wood DE, Qaseem A, Detterbeck FC. Benefits and harms of CT screening for lung cancer: a systematic review. JAMA. 2012 Jun 13;307(22):2418-29. doi: 10.1001/jama.2012.5521.
Reference Type
BACKGROUND
National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
Reference Type
BACKGROUND
Oken MM, Hocking WG, Kvale PA, Andriole GL, Buys SS, Church TR, Crawford ED, Fouad MN, Isaacs C, Reding DJ, Weissfeld JL, Yokochi LA, O'Brien B, Ragard LR, Rathmell JM, Riley TL, Wright P, Caparaso N, Hu P, Izmirlian G, Pinsky PF, Prorok PC, Kramer BS, Miller AB, Gohagan JK, Berg CD; PLCO Project Team. Screening by chest radiograph and lung cancer mortality: the Prostate, Lung, Colorectal, and Ovarian (PLCO) randomized trial. JAMA. 2011 Nov 2;306(17):1865-73. doi: 10.1001/jama.2011.1591. Epub 2011 Oct 26.
Reference Type
BACKGROUND
Humphrey LL, Deffebach M, Pappas M, Baumann C, Artis K, Mitchell JP, Zakher B, Fu R, Slatore CG. Screening for lung cancer with low-dose computed tomography: a systematic review to update the US Preventive services task force recommendation. Ann Intern Med. 2013 Sep 17;159(6):411-420. doi: 10.7326/0003-4819-159-6-201309170-00690.
Reference Type
BACKGROUND
US Preventive Services Task Force; Krist AH, Davidson KW, Mangione CM, Barry MJ, Cabana M, Caughey AB, Davis EM, Donahue KE, Doubeni CA, Kubik M, Landefeld CS, Li L, Ogedegbe G, Owens DK, Pbert L, Silverstein M, Stevermer J, Tseng CW, Wong JB. Screening for Lung Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2021 Mar 9;325(10):962-970. doi: 10.1001/jama.2021.1117.
Reference Type
BACKGROUND
Suzuki K, Nagai K, Yoshida J, Ohmatsu H, Takahashi K, Nishimura M, Nishiwaki Y. Video-assisted thoracoscopic surgery for small indeterminate pulmonary nodules: indications for preoperative marking. Chest. 1999 Feb;115(2):563-8. doi: 10.1378/chest.115.2.563.
Reference Type
BACKGROUND
Santambrogio R, Montorsi M, Bianchi P, Mantovani A, Ghelma F, Mezzetti M. Intraoperative ultrasound during thoracoscopic procedures for solitary pulmonary nodules. Ann Thorac Surg. 1999 Jul;68(1):218-22. doi: 10.1016/s0003-4975(99)00459-2.
Reference Type
BACKGROUND
Kim YD, Jeong YJ, I H, Cho JS, Lee JW, Kim HJ, Lee SH, Kim DH. Localization of pulmonary nodules with lipiodol prior to thoracoscopic surgery. Acta Radiol. 2011 Feb 1;52(1):64-9. doi: 10.1258/ar.2010.100307.
Reference Type
BACKGROUND
Mayo JR, Clifton JC, Powell TI, English JC, Evans KG, Yee J, McWilliams AM, Lam SC, Finley RJ. Lung nodules: CT-guided placement of microcoils to direct video-assisted thoracoscopic surgical resection. Radiology. 2009 Feb;250(2):576-85. doi: 10.1148/radiol.2502080442.
Reference Type
BACKGROUND
Finley RJ, Mayo JR, Grant K, Clifton JC, English J, Leo J, Lam S. Preoperative computed tomography-guided microcoil localization of small peripheral pulmonary nodules: a prospective randomized controlled trial. J Thorac Cardiovasc Surg. 2015 Jan;149(1):26-31. doi: 10.1016/j.jtcvs.2014.08.055. Epub 2014 Sep 16.
Reference Type
BACKGROUND
Cheng C, Fang HY, Wen CT, Chao YK. Real-time image-guided electromagnetic navigation bronchoscopy dual-marker technique to localize deep pulmonary nodules in a hybrid operating room. Eur J Cardiothorac Surg. 2020 Aug 1;58(Suppl_1):i103-i105. doi: 10.1093/ejcts/ezz360.
Reference Type
BACKGROUND
Sadoughi A, Virdi S. Mobile 3D Intraprocedural Fluoroscopy in Combination With Ultrathin Bronchoscopy for Biopsy of Peripheral Lung Nodules. J Bronchology Interv Pulmonol. 2021 Jan 1;28(1):76-80. doi: 10.1097/LBR.0000000000000711.
Reference Type
BACKGROUND
Kpodonu J, Raney A. The cardiovascular hybrid room a key component for hybrid interventions and image guided surgery in the emerging specialty of cardiovascular hybrid surgery. Interact Cardiovasc Thorac Surg. 2009 Oct;9(4):688-92. doi: 10.1510/icvts.2009.209429. Epub 2009 Jul 21.
Reference Type
BACKGROUND
Biasi L, Ali T, Ratnam LA, Morgan R, Loftus I, Thompson M. Intra-operative DynaCT improves technical success of endovascular repair of abdominal aortic aneurysms. J Vasc Surg. 2009 Feb;49(2):288-95. doi: 10.1016/j.jvs.2008.09.013. Epub 2008 Nov 28.
Reference Type
BACKGROUND
Heran NS, Song JK, Namba K, Smith W, Niimi Y, Berenstein A. The utility of DynaCT in neuroendovascular procedures. AJNR Am J Neuroradiol. 2006 Feb;27(2):330-2.
Reference Type
BACKGROUND
Irie K, Murayama Y, Saguchi T, Ishibashi T, Ebara M, Takao H, Abe T. Dynact soft-tissue visualization using an angiographic C-arm system: initial clinical experience in the operating room. Neurosurgery. 2008 Mar;62(3 Suppl 1):266-72; discussion 272. doi: 10.1227/01.neu.0000317403.23713.92.
Reference Type
BACKGROUND
Fang HY, Chao YK, Hsieh MJ, Wen CT, Ho PH, Tang WJ, Liu YH. Image-guided video-assisted thoracoscopic surgery for small ground glass opacities: a case series. J Vis Surg. 2017 Oct 18;3:142. doi: 10.21037/jovs.2017.09.08. eCollection 2017.
Reference Type
BACKGROUND
Hsieh MJ, Wen CT, Fang HY, Wen YW, Lin CC, Chao YK. Learning curve of image-guided video-assisted thoracoscopic surgery for small pulmonary nodules: A prospective analysis of 30 initial patients. J Thorac Cardiovasc Surg. 2018 Apr;155(4):1825-1832.e1. doi: 10.1016/j.jtcvs.2017.11.079. Epub 2017 Dec 13.
Reference Type
BACKGROUND
Chao YK, Wen CT, Fang HY, Hsieh MJ. A single-center experience of 100 image-guided video-assisted thoracoscopic surgery procedures. J Thorac Dis. 2018 Jun;10(Suppl 14):S1624-S1630. doi: 10.21037/jtd.2018.04.44.
Reference Type
BACKGROUND
Chao YK, Pan KT, Wen CT, Fang HY, Hsieh MJ. A comparison of efficacy and safety of preoperative versus intraoperative computed tomography-guided thoracoscopic lung resection. J Thorac Cardiovasc Surg. 2018 Nov;156(5):1974-1983.e1. doi: 10.1016/j.jtcvs.2018.06.088. Epub 2018 Jul 20.
Reference Type
BACKGROUND
Fang HY, Chang KW, Chao YK. Hybrid operating room for the intraoperative CT-guided localization of pulmonary nodules. Ann Transl Med. 2019 Jan;7(2):34. doi: 10.21037/atm.2018.12.48.
Reference Type
BACKGROUND
Gill RR, Zheng Y, Barlow JS, Jayender J, Girard EE, Hartigan PM, Chirieac LR, Belle-King CJ, Murray K, Sears C, Wee JO, Jaklitsch MT, Colson YL, Bueno R. Image-guided video assisted thoracoscopic surgery (iVATS) - phase I-II clinical trial. J Surg Oncol. 2015 Jul;112(1):18-25. doi: 10.1002/jso.23941. Epub 2015 May 28.
Reference Type
BACKGROUND
Ng CSH, Man Chu C, Kwok MWT, Yim APC, Wong RHL. Hybrid DynaCT scan-guided localization single-port lobectomy. [corrected]. Chest. 2015 Mar;147(3):e76-e78. doi: 10.1378/chest.14-1503.
Reference Type
BACKGROUND
Rouze S, de Latour B, Flecher E, Guihaire J, Castro M, Corre R, Haigron P, Verhoye JP. Small pulmonary nodule localization with cone beam computed tomography during video-assisted thoracic surgery: a feasibility study. Interact Cardiovasc Thorac Surg. 2016 Jun;22(6):705-11. doi: 10.1093/icvts/ivw029. Epub 2016 Feb 26.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
202100442A3
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Feasibility Study of Anatomical Modeling for Image Guided Thoracic Surgery
NCT05046067
COMPLETED
NA
Real-Time Non-Invasive Localization for Multiple Lung Nodules
NCT07257549
COMPLETED
NA
Comparison of Segmentectomy Versus Lobectomy for Non-small Cell Lung Cancer ≤ 2 cm in the Middle Third of the Lung Field
NCT04944563
RECRUITING
NA
CT-based Radiomic Algorithm for Assisting Surgery Decision and Predicting Immunotherapy Response of NSCLC
NCT04452058
UNKNOWN
Safety and Effectiveness of Disposable Pulmonary Surgical Markers in the Localization of Pulmonary Nodules
NCT04139408
COMPLETED
NA
Construction and Evaluation of the Liquid Biopsy-based Early Diagnostic Model for Lung Cancer
NCT04156360
UNKNOWN
Comparison Between Wedge Resection and Segmentectomy for Ground Glass Opacity- Dominant Stage IA NSCLC
NCT02718365
UNKNOWN
NA
Acute and Chronic Pain After Video-assisted Thoracoscopic Surgery for Lung Cancer
NCT05478460
COMPLETED
Radical Resection With Contralateral Lymph Node Dissection for Clinical N3 NSCLC
NCT07003490
RECRUITING
NA
cfDNA Methylation Assay for Clinical Evaluation of Patients With Stage IA Lung Cancer After Ablation Operation
NCT04413656
UNKNOWN
NA
Diagnostic Value of Confocal Laser Endomicroscopy (CelTouch) for Peripheral Lung Lesions
NCT07004946
RECRUITING
Cost-consequence Analysis of Parenchymal Stapling Device Versus Hand-sewing for Pulmonary Lobectomy in Lung Disease
NCT01575314
COMPLETED
NA
Detection of Circulating Tumour Cells, Spread Through Air Space in Patients With Lung Cancer
NCT06833632
RECRUITING
A Study to Explore the Early Subjective Evaluation and Objective Recovery in Lung Cancer Patients Undergoing Sublobar Resection Versus Lobectomy
NCT07288710
RECRUITING
Augmented Reality Assisted Lung Nodule Localization: a Multicentered, Prospective, Randomly Controlled, Non-inferiority Trial
NCT06548451
COMPLETED
NA
Robotic-Assisted Navigation for Lung Nodule Localization: A Non-Inferiority Study
NCT07055997
COMPLETED
NA
Low-dose Protocol for Computed Tomography-guided Lung Biopsy
NCT02971176
COMPLETED
NA
3D Printing for Nodule Localization
NCT04056923
COMPLETED
NA
AI Determine Malignancy of GGO on Chest CT
NCT06282068
ENROLLING_BY_INVITATION
Diagnosis of Individuals With Pulmonary Nodules by Different Bronchoscopy Combination
NCT02268162
UNKNOWN
NA
Evaluation of Clinical Significance and Feasibility of CT Guided Biopsy of Double Site Lesions：A Preliminary Lung Centered Study
NCT04960631
COMPLETED
Reduced Dissemination of Tumor Cells With Primary Ligation of the Vein in Patients With Lung Cancer
NCT03436329
UNKNOWN
NA
Low-dose Computed Tomography-guided Core Needle Biopsy for Lung Nodules
NCT04217655
COMPLETED
NA
Combined Segmentectomy Versus Lobectomy for Stage IA Lung Adenocarcinoma With Ground-glass Component of Prospective, Randomized, Controlled Clinical Study
NCT05983835
UNKNOWN
NA
Thoracoscopic Lobectomy Using Nonintubated Anesthesia Versus Intubated General Anesthesia for Lung Cancer Patients
NCT01533233
UNKNOWN
PHASE1/PHASE2