Clinical trials: Pulmonary Nodules, Multiple
Pulmonary Nodules
Diagnostic and Monitoring Significance of ctDNA Methylation Analysis by NGS in Benign and Malignant Pulmonary Nodules
AnchorDx is using circulating tumor DNA (ctDNA) methylation analysis by next-generation sequencing (NGS) to develop a blood-based assay for differentiating benign and malignant pulmonary nodules early.
- Trial name
- NCT03651986
- Testing
- ctDNA methylation analysis by NGS
- Where
- 23 sites in China
- Volunteers
- 10,560 people, healthy volunteers welcome
- Sponsor
- AnchorDx Medical Co., Ltd.
Lung Cancer (Diagnosis), Lung Nodule
A Randomized Controlled Trial Comparing Percutaneous CT-Guided Biopsy and Shape-Sensing Robotic-Assisted Bronchoscopy
The ENCOMPASS study is a post-market, multicenter, randomized controlled trial comparing two established approaches for obtaining a biopsy of small pulmonary nodules (≤2 cm): CT-guided percutaneous lung nodule biopsy and…
- Trial name
- ENCOMPASS (NCT07761351)
- Testing
- Shape-Sensing Robotic-Assisted Bronchoscopy with Cone-Beam CT (ssRAB with CBCT), CT-guided percutaneous lung nodule biopsy
- Where
- 3 sites in Germany, Switzerland and 1 more
- Volunteers
- 550 people
- Sponsor
- Intuitive Surgical
Pulmonary Nodule, Solitary, Whole-genome Methylation Sequencing
Benign/Malignant Pulmonary Nodule Classification Based on High-throughput Whole-genome Methylation Sequencing(GM-seq)
Lung cancer is the first cancer in China in terms of morbidity and mortality. The problem of early diagnosis/treatment has always been concerned.
- Trial name
- NCT05415670
- Testing
- Whole-genome Methylation Sequencing(GM-seq)
- Where
- 2 sites in China
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- Geneplus-Beijing Co. Ltd.
Precancerous Conditions, Carcinoma
Early Diagnosis of Pulmonary Nodules
This study is intended to determine the positive predictive value (PPV) and negative predictive value (NPV) of the multiprotein classifier based on the observed study prevalence of Non-Small Cell Lung Cancer (NSCLC) in the study…
- Trial name
- NCT01752114
- Where
- 33 sites in United States, Canada
- Volunteers
- 684 people, healthy volunteers welcome
- Sponsor
- Integrated Diagnostics
Lung Cancer
All in One Study: A Prospective Trial of Electromagnetic Navigation for Biopsy of Pulmonary Nodules
This is a multi-center, non-randomized, single-arm, prospective trial to evaluate a staged sampling methodology designed to maximize the diagnostic yield of lung biopsy in a single procedure setting.
- Trial name
- AIO (NCT03338049)
- Testing
- Veran System
- Where
- 9 sites in United States
- Volunteers
- 150 people
- Sponsor
- Veran Medical Technologies
Lung Lesion(s) Requiring Evaluation, Pulmonary Metastasis
Percutaneous Localization: Open-label Registry of Thoracic Surgery
The objectives of this study are to evaluate intraoperative percutaneous lung lesion marking assisted by electromagnetic guided percutaneous navigation and related tools.
- Conditions
- Lung Lesion(s) Requiring Evaluation, Pulmonary Metastasis, Pulmonary Nodule, Solitary, Peripheral Lung Lesions
- Trial name
- PLOTS (NCT04066699)
- Testing
- Percutaneous localization of suspicious lung lesion(s) using electromagnetic navigation and tools.
- Where
- 5 sites in United States
- Volunteers
- 70 people
- Sponsor
- Veran Medical Technologies
Lung Cancer
Diagnostic Study for Lung Cancer Detection Test
Early detection of lung cancer and early removal of the cancer nodules facilitates the diagnosis and treatment. However, not all nodules are malignant.
- Trial name
- NCT01700452
- Where
- 6 sites in United States, Israel
- Volunteers
- 173 people
- Sponsor
- Bioview, Inc.
Pulmonary Nodule, Solitary, Lung Cancer
Clinical Utility of Management of Patients With Pulmonary Nodules Using the Percepta Nasal Swab Classifier
The goal of this observational study is to learn how a physician uses the results of the Percepta® Nasal Swab test to manage people with a newly identified pulmonary nodule.
- Trial name
- NIGHTINGALE (NCT06426628)
- Where
- 23 sites in United States, Puerto Rico
- Volunteers
- 2,400 people
- Sponsor
- Veracyte, Inc.
Pulmonary Nodules
DOuBLED - Doubling Outcomes by Lung Cancer Early Diagnosis
Early diagnosis of LC in the asymptomatic stage through intentional screening programs and/or incidental pulmonary nodule identification and follow-up are known to improve outcomes significantly.
- Trial name
- DOuBLED (NCT05091437)
- Testing
- Observational study
- Where
- 14 sites in Argentina, Brazil and 6 more
- Volunteers
- 562 people
- Sponsor
- AstraZeneca
Lung Cancer, Multiple Pulmonary Nodules
Real World Registry for Use of the Ion Endoluminal System
The primary objective of this study is to evaluate the performance of the Ion Endoluminal System with real-world use for pulmonary lesion localization or biopsy.
- Conditions
- Lung Cancer, Multiple Pulmonary Nodules, Lung Neoplasms, Respiratory Tract Neoplasms
- Trial name
- NCT06004440
- Testing
- Ion Endoluminal System
- Where
- 16 sites in United States
- Volunteers
- 1,301 people
- Sponsor
- Intuitive Surgical
Pulmonary Nodules, Multiple, Pulmonary Nodules, Solitary
Differentiation of Benign and Malignant Pulmonary Nodules by Volatile Organic Compounds in Human Exhaled Breath
The goal of this observational study is to develop an advanced expiratory algorithm model utilizing exhaled breath volatile organic compound (VOC) markers.
- Conditions
- Pulmonary Nodules, Multiple, Pulmonary Nodules, Solitary, Lung Cancer
- Trial name
- NCT06518655
- Testing
- Gas chromatography-mass spectrometry(GC-MS) and micro Gas Chromatography-photoionisation detector (μGC-PID) system
- Where
- 15 sites in China
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- ChromX Health
Solitary Pulmonary Nodule, Multiple Pulmonary Nodules
iNod™ Ultrasound-Guided Needle Biopsy System Study
The purpose of this study is to collect information on the iNod™ System's safety and ability to see the iNod™ biopsy needle in real-time in endobronchial lesions, peripheral lung nodules, or lung masses.
- Conditions
- Solitary Pulmonary Nodule, Multiple Pulmonary Nodules, Biopsy, Fine-Needle
- Trial name
- NCT05804435
- Testing
- iNod™ System
- Sponsor
- Boston Scientific Corporation
Solitary Pulmonary Nodules
Clinical Evaluation of CARESTREAM Dual Energy and Digital Tomosynthesis
The purpose of this study is to evaluate the imaging performance of Dual Energy and Digital Tomosynthesis (DE-DT) application against the commercially available predicate devices.
- Trial name
- NCT02531646
- Testing
- Radiation
- Volunteers
- 66 people
- Sponsor
- Carestream Health, Inc.
High Risk Cancer
Standalone Observational Study Assessing the Performance of an AI/ML Tech-based SaMD on Chest LDCT Images (REALITY)
This is a Multinational, Multicenter, retrospective study for the evaluation of the standalone efficacy and safety of an Artificial Intelligence/Machine Learning (AI/ML) technology-based end-to-end Computer assisted…
- Trial name
- REALITY (NCT06576232)
- Testing
- Median LCS
- Where
- 5 sites in United States, Spain
- Volunteers
- 1,147 people, healthy volunteers welcome
- Sponsor
- Median Technologies
Lung Cancer (Diagnosis)
Blood Sample Collection in Subjects With Pulmonary Nodules or CT Suspicion of Lung Cancer or Pathologically Diagnosed Lung Cancer
The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens for use in assessing new biomarkers for the detection of neoplasms of the lung.
- Trial name
- NCT03633006
- Testing
- Blood Sample Collection
- Where
- 83 sites in United States
- Volunteers
- 3,298 people
- Sponsor
- Exact Sciences Corporation
Pulmonary Nodule, Lung Cancer
European Real-World Registry for Use of the Ion Endoluminal System
The objective of this study is to collect collect real-world data for the Ion endoluminal system.
- Trial name
- NCT06923774
- Testing
- Ion endoluminal system
- Where
- 9 sites in France, Germany and 2 more
- Volunteers
- 1,200 people
- Sponsor
- Intuitive Surgical
Lung Cancer
Safety and Effectiveness of Disposable Pulmonary Surgical Markers in the Localization of Pulmonary Nodules
During the VATS procedure, some pulmonary nodules are relatively small or far away from the pleura, resulting that they are difficult to be accurately located during the procedure.
- Trial name
- NCT04139408
- Testing
- Disposable Pulmonary Surgical Marker
- Where
- 3 sites in China
- Volunteers
- 76 people
- Sponsor
- Hangzhou Broncus Medical Co., Ltd.
High Risk Cancer, Lung Cancer
Retrospective Clinical Trial Comparing Radiologists' Diagnosis Accuracy in Lung Cancer Screening Population With and Without the Help of an AI/ML Tech-based SaMD
This is a two arm, randomized, controlled, blinded, multi-case multi reader (MRMC), retrospective study for the evaluation of the efficacy and safety of an AI/ML technology-based CADe/x developed to detect, localize and…
- Trial name
- RELIVE (NCT06751576)
- Testing
- Median LCS
- Where
- 5 sites in United States, Spain
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- Median Technologies
Lung Cancer, Nodes, Lung
Confirmation of Accuracy of the Tool-in-lesion Technology (TiLT) of the Galaxy System With Integrated TOMO Technology
This study will evaluate the feasibility of performing robotic navigation of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.
- Trial name
- TiLT (NCT06056128)
- Testing
- Robotic assisted bronchoscopy
- Where
- Hong Kong
- Volunteers
- 25 people
- Sponsor
- Noah Medical
Solitary Pulmonary Nodule, Multiple Pulmonary Nodules
A Multi-Center Trial of the ProLung Test™
The primary Study hypothesis is that the ProLung Test will demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious for lung cancer.
- Trial name
- NCT01566682
- Where
- 15 sites in United States
- Volunteers
- 420 people
- Sponsor
- Fresh Medical Laboratories