Clinical trials: Pulmonary Nodules
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
Solitary Pulmonary Nodule
Evaluate the Auxiliary Diagnostic Value of Circulating Tumor Cells in Benign and Malignant Lung Nodules
By testing the CTC number of new solitary pulmonary nodule patient, evaluating the correlation of CTC number and benign and malignant lung nodules auxiliary diagnosis, the correlation of CTC number and the size of lung nodules of…
- Trial name
- NCT02653859
- Volunteers
- 50 people
- Sponsor
- GenoSaber
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
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.
Lung Diseases
Image - Navigated Resection of Lung Nodules
This is an open label study lung nodules that are either cancer or non-cancer and who are eligible for surgical resection. Patients will undergo their surgery with the help of the Lung Resection Marker Locator Kit which will…
- Trial name
- NCT04702165
- Testing
- lung resection with Lung Resection Marker Locator Kit
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Navigation Sciences, Inc.
Lung Cancer (Diagnosis)
Robotic Bronchoscopy for Small Lung Nodules Without a Bronchus Sign
The goal of this observational study is to learn about the diagnostic performance and safety of robotic-assisted bronchoscopy using the Ion Endoluminal System in adults with small lung nodules that do not show a bronchus sign on…
- Trial name
- NCT07862816
- Where
- 4 sites in South Korea
- Volunteers
- 151 people
- Sponsor
- Intuitive Surgical
Lung Neoplasms, Lung Cancer
ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting
This is a phase 3, multi-center, single dose, open-label, exploratory study in suspected lung cancer patients scheduled to undergo endoscopic or thoracic surgery per CT/PET/MRI or other imaging based on standard of care.
- Trial name
- Elucidate (NCT04241315)
- Testing
- OTL38 for Injection, Near infrared camera imaging system
- Where
- 12 sites in United States
- Volunteers
- 112 people
- Sponsor
- On Target Laboratories, LLC
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
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 Neoplasms, Lung Cancer
OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules
This is a phase 2, multi-center, single dose, open-label, exploratory study in suspected lung cancer patients scheduled to undergo endoscopic or thoracic surgery per CT/positron emission tomography imaging based on standard of…
- Trial name
- NCT02872701
- Testing
- OTL38 for Injection, Near infrared camera imaging system, Endoscopic or Thoracic Surgery
- Where
- 6 sites in United States, Netherlands
- Volunteers
- 100 people
- Sponsor
- On Target Laboratories, LLC
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.
Lung Cancer (Diagnosis)
Evaluate the Clinical Performance of the Flow Cytometry - FlowPath Lung Test as a Sensitive and Specific Non-invasive Diagnostic of Sputum Samples to Identify/Detect the Presence of Lung Cancer in High-risk Individuals Who Have Existing Lung Nodules, 6 to <30 mm in Diameter, Determined by LDCT.
Evaluate FlowPath Lung Diagnostic Test of Sputum Samples to Detect the Presence of Lung Cancer in High-risk Individuals Who Have Existing Lung Nodules, >6 to <30 mm in Diameter, Determined by LDCT.
- Trial name
- BA-004 (NCT07168993)
- Testing
- Standard medical treatment
- Where
- 11 sites in United States
- Volunteers
- 2,063 people
- Sponsor
- bioAffinity Technologies Inc.
Solitary Pulmonary Nodule, Multiple Pulmonary Nodules
LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules
Correlate performance of LungLB Test with outcome of a scheduled biopsy.
- Trial name
- NCT05171491
- Where
- 12 sites in United States
- Volunteers
- 425 people
- Sponsor
- LungLife AI
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.
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
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
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
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 (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, 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.