Clinical trials: Lung Nodule
Lung Cancer Diagnosis
Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening
The PROACT LUNG study is a prospective multi-center observational study to validate a blood-based test for the early detection of lung cancer by collecting blood samples from high-risk participants who will undergo a routine…
- Trial name
- PROACT-LUNG (NCT06122077)
- Testing
- blood draw
- Where
- 36 sites in United States
- Volunteers
- 20,000 people
- Sponsor
- Freenome Holdings Inc.
Lung Malignancy
Validating Artificial Intelligence Effectiveness Defined Lung Nodule Malignancy Score in Patients With Pulmonary Nodule.
Artificial intelligence (AI) based algorithms have demonstrated increased accuracy in predicting the risk of Lung Cancer among patients with an incidental pulmonary nodule (IPN) on chest radiographs.
- Trial name
- CREATE (NCT05817110)
- Testing
- Participant Cohort
- Where
- 22 sites in Egypt, India and 3 more
- Volunteers
- 712 people
- Sponsor
- AstraZeneca
Pulmonary Nodules
A Prospective Cohort Study of Chinese Patients With Pulmonary Nodules: Prediction of Lung Cancer Using Noninvasive Biomarkers
The broad goals of this study is to identify changes in genomic landscape during transition from stage 0 to stage 1 lung cancer.
- Trial name
- NCT04462185
- Testing
- A genomic and transcriptomic landscape analysis
- Where
- 6 sites in China
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- AnchorDx Medical Co., Ltd.
Pulmonary Nodule, Lung Cancer
Clinical Utility for Ion Endoluminal System
The goal of this prospective, multi-center, single-arm, clinical study is to evaluate the clinical utility and performance of the FDA-cleared Ion™ Endoluminal System ("Ion") for bronchoscopically approaching and facilitating the…
- Conditions
- Pulmonary Nodule, Lung Cancer, Lung Diseases
- Trial name
- NCT03893539
- Testing
- Ion Endoluminal System™
- Where
- 6 sites in United States
- Volunteers
- 365 people
- Sponsor
- Intuitive Surgical
Lung Cancer
A Multicenter Study to Evaluate the Cios Spin and the Ion Endoluminal System for Pulmonary Nodule Biopsy
The overall objective of this study is to evaluate procedure characteristics of pulmonary nodule biopsies using the integrated version of Cios Spin and the Ion Endoluminal System.
- Trial name
- NCT05562895
- Testing
- Ion Endoluminal System and Cios Spin
- Where
- 6 sites in United States
- Volunteers
- 155 people
- Sponsor
- Intuitive Surgical
Pulmonary Coin Lesion
Pilot Study to Measure Lung Biopsy Diagnostic Yield Using Always On Electromagnetic Tip Tracked Devices
The objective of the prospective, multi-center study is to evaluate the ease of use and effectiveness of the SPiN Drive Electromagnetic (EM) Tip Tracked Steerable Devices as a method of sampling subsegmental, less than 3.0 cm…
- Trial name
- ALOSPNDY (NCT01389154)
- Testing
- Lung biopsy using Always On EM Tip Tracked Device
- Sponsor
- Veran Medical Technologies
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
Lung Cancer
Evaluation of the Archimedes™ System for Transparenchymal Nodule Access
The Archimedes System is an image-guided navigation system used to access tissue samples in the lungs. This study is being conducted to confirm the performance of the Archimedes System in patients who are scheduled for standard…
- Trial name
- EAST (NCT02460120)
- Testing
- Archimedes System
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Broncus Medical Inc
Nodule Solitary Pulmonary, NSCLC
A Registry to Evaluate the Performance of the BDX-XL2 Test
The purpose of the ORACLE Registry is to demonstrate clinical utility of the BDX-XL2 test; specifically, the potential to reduce unnecessary invasive procedures, such as biopsies and surgeries, on benign lung nodules while not…
- Trial name
- ORACLE (NCT03766958)
- Where
- 15 sites in United States
- Volunteers
- 842 people
- Sponsor
- Biodesix, Inc.
Pulmonary Nodule, Solitary, Lung Cancer
A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB
Multi-center randomized controlled study designed to compare the diagnostic yield of ION™ Endoluminal System with electromagnetic navigation bronchoscopy in patients undergoing transbronchial sampling procedure of peripheral…
- Trial name
- ARTICULAtE (NCT06308120)
- Testing
- Ion Endoluminal System, superDimension Navigation System and Accessories
- Where
- 3 sites in China
- Volunteers
- 354 people
- Sponsor
- Intuitive Surgical
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.
Cancer of the Lung, Lung Cancer
Circulating Tumor DNA in Patients at High Risk for Lung Cancer
Patients who are about to undergo a diagnostic or therapeutic bronchoscopy or thoracic surgery without a distant history of cancer will have their blood drawn for measurement of circulating tumor DNA (ctDNA) to validate the…
- Conditions
- Cancer of the Lung, Lung Cancer, Lung Neoplasms, Adenocarcinoma of the Lung
- Trial name
- NCT02715102
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Pathway Genomics
Solitary Pulmonary Nodule, Multiple Pulmonary Nodules
Evaluate the Utility of the ProLung Test as Adjunctive to CT Scan in the Diagnosis of Lung Cancer
A Study to evaluate the utility of the ProLung Test as an adjunct to CT scan in the diagnosis of lung cancer.
- Trial name
- NCT01958931
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Fresh Medical Laboratories
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
Lung Cancer, Pulmonary Nodule, Solitary
Prospective Post-market Data Collection for Ion Endoluminal System to Understand CT to Body Divergence
The goal of this study is to collect post-market data for the Ion Endoluminal System to understand CT to body divergence.
- Trial name
- NCT04735341
- Testing
- Ion Endoluminal System
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Intuitive Surgical
Lung Cancer Screening
Clinical Evaluation of the Lung Cancer AI-based Decision Support Tool in Low-Dose Lung CT
The goal of this observational study is to clinically validate the accuracy of an AI-based decision support tool-the Lung Cancer Detection System (LCDS)-for detecting lung nodules in asymptomatic adults aged 50-79 with a history…
- Trial name
- GenMedAILCSD1 (NCT07052773)
- Testing
- Lung Cancer Detection System (LCDS)
- Where
- Israel
- Volunteers
- 100 people
- Sponsor
- Genesis Medical AI
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
Lung Nodules
A Multicenter, Retrospective, Chart Review Study Evaluating the Impact and Utility of the Blood-Based Proteomic Integrated Classifier and Auto-Antibody Tests in the Real-World
This study is a multicenter retrospective chart review. Sites with at least 100 patients tested with the IC and AAT tests, who have index dates (date of IC and AAT testing) at least one year prior to data collection date will be…
- Trial name
- CLARIFY (NCT06728319)
- Where
- 5 sites in United States
- Volunteers
- 4,000 people
- Sponsor
- Biodesix, Inc.
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.
Solitary Pulmonary Nodule, Biopsy, Fine-Needle
iNod System Human Feasibility Assessment
The purpose of this study is to demonstrate feasibility to access, visualize, and obtain specimens adequate for cytology of lung lesions in subjects with suspected lung cancer when using the iNod System.
- Trial name
- iNod (NCT02832284)
- Testing
- iNod System
- Where
- 3 sites in United States
- Volunteers
- 23 people
- Sponsor
- Boston Scientific Corporation