Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Multiple Pulmonary Nodules

Solitary Pulmonary Nodule

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Virtual bronchoscopy navigation (VBN) calculates the access to a solitary pulmonary nodule via a trans-parenchymal route. In contrast to the gold Standard transthoracic approach, with this technique also very small lesions (7 mm diameter), and lesions which cannot be reached via the transthoracic route - located in the inner two thirds of the lung - can be approached.

Virtual bronchoscopic navigation

Dirk-Jan Slebos, MD PhD

Birgitta Hiddinga, MD

Background Transthoracic computed tomography (CT)-guided procedures are the current gold Standard for obtaining diagnostic biopsies of solitary pulmonary nodules (SPN) in the peripheral lung. Novel endobronchial techniques, such as electromagnetic navigation bronchoscopy (ENB) or Virtual bronchoscopic navigation (VBN) are considered safer to approach SPNs.

The newest technique combines VBN with calculating the access to a SPN via a transparenchymal route. In contrast to the gold Standard transthoracic approach, also small lesions, and lesions which cannot be reached transthoracicaliy, located in the innertwo thirdsof the lung can be approached.

Main research question To assess diagnostic yield of the novel Standard of care 'Virtual bronchoscopy navigation" procedure.

Design (including population, confounders/outcomes) A single centre, prospective, observational study of patients undergoing the novel Standard of care Virtual bronchoscopy navigation procedure to assess a pulmonary nodule. Clinical data of at least 100 consecutive patients will be collected.

Background Transthoracic computed tomography (CT)-guided procedures are the current gold Standard for obtaining diagnostic biopsies of solitary pulmonary nodules (SPN) in the peripheral lung. Despite its accuracy and diagnostic yield, this technique is associated with an increased risk of complications, Pneumothorax and severe bleeding are the most frequent complications occurring in up to 27% of cases each.

Novel endobronchial techniques, such as electromagnetic navigation bronchoscopy (ENB) or Virtual bronchoscopic navigation (VBN) are considered safer to approach SPNs. The overall rate of pneumothorax after ENB is 4.3%, and bleeding occurs in only 2.8% of cases. The combination of techniques led to an overall increase of the diagnostic yield.

The newest technique combines VBN with calculating the access to a SPN via a transparenchymal route. In contrast to the gold Standard transthoracic approach, also small lesions, and lesions which cannot be reached transthoracicaliy, located in the innertwo thirdsof the lung can be approached. Detailed clinical data, like the correlation of the diagnostic yield to the specific location of the pulmonary nodule, however, is lacking. In view of the expected lung cancer screening program leading to increasing numbers of especially small pulmonary nodules, this data, however, is considered useful to help to select patients forthe right diagnostic procedure.

Main research question To assess diagnostic yield of the novel Standard of care 'Virtual bronchoscopy navigation" procedure.

Design (including population, confounders/outcomes) A single centre, prospective, observational study of patients undergoing the novel Standard of care Virtual bronchoscopy navigation procedure to assess a pulmonary nodule. Clinical data of at least 100 consecutive patients will be collected.

Expected results With the VBN procedure a histologie diagnosis of a SPN can be obtained safely with high diagnostic yield. Correlation to detailed clinical data is expected to help selecting patients for this procedure in the future.

In the future add on technique such as confocal laser endomicroscopy and fluorescence molecular endoscopy might further improve identification of the lesion during the procedure. Ultimately, we expect that development of this technique will pave the way to a one-stop-shop approach with rapid on-site evaluation followed by local treatment (e.g. microwave ablation) of the malignant pulmonary nodule.

Virtual Bronchoscopic Navigation to Increase Diagnostic Yield in Patients With Pulmonary Nodules

Number of procedures with success to access the solitary pulmonary nodule

University Medical Center Groningen

Md PhD

Symptoms and General Pathology

Neoplastic Cells, Circulating

Patients with pulmonary nodules less than 3cm on CT imaging.

Guangying Zhu, M.D.

The goal of this observational clinical trial is to evaluate the value of circulating tumor cell detection in the early diagnosis of malignant pulmonary nodule. The main questions it aims to answer is: the sensitivity and specificity of peripheral blood circulating tumor cell detection in differentiating benign and malignant pulmonary nodules (\<3cm). Participants will be asked provide 4mL of peripheral blood for the test.

The aim of this clinical trial is to evaluate the value of circulating tumor cell detection in the early diagnosis of malignant pulmonary nodule. Patients with clinical suspected malignant pulmonary nodules will be included in this trial. Peripheral blood of participants will be collected before surgery or biopsy. Clinical and imaging data of enrolled patients will also be collected. Pathological diagnosis is the gold standard for differentiating benign and malignant pulmonary nodules. The sensitivity and specificity of CTC detection for diagnosing malignant pulmonary nodules will be analyzed.

Early Adjuvant Diagnosis of Pulmonary Nodules Based on CTC.

Early Adjuvant Diagnosis Clinical Trial of Pulmonary Nodules Based on Circulating Tumor Cells.

Original research data including study protocol and statistical analysis plan will be shared after the study is completed and the research results are published.

the ability of peripheral blood CTC count detection to identify malignant pulmonary nodules when the real condition is malignancy

the ability of peripheral blood CTC count detection to exclude malignant pulmonary nodules when the real condition is benign disease

China-Japan Friendship Hospital

chief physician

Heart and Blood Diseases

Nutritional and Metabolic Diseases

Digestive System Diseases

Rare Diseases

Pleural Effusion

Emergencies

Fibrosis

Pulmonary Atelectasis

Cardiomegaly

Calcinosis

Pneumothorax

Pneumoperitoneum

Pulmonary Fibrosis

Pleural Diseases

Peritoneal Diseases

Gastrointestinal Diseases

Lung Diseases, Interstitial

Heart Diseases

Hypertrophy

Pathological Conditions, Anatomical

Chronic Graft Versus Host Disease

Acute Graft Versus Host Disease

Reader Selection: 30 readers will be selected from the following five clinical specialty groups:

* emergency medicine (ED)
* adult intensive care (ICU)
* adult general medicine (AGM)
* radiographers (Rad)
* general radiologists

Each specialty group consists of 6 members of ranked seniority. For the physicians this consists of:

* Two 'Juniors' (Foundation Year 1 - Specialty Training 2 years)
* Two 'Middle Grades' (Registrar from Specialty Training 3 to 6 years)
* Two Consultants

For the radiographers, this consists of:

* Two 'Junior/Newly qualified radiographers' (up to 18 months experience post qualification)
* Two 'Mid-experience radiographers' (approx. 3 years' experience)
* Two 'Reporting radiographers' (5+ years' experience)

Two consultant thoracic radiologists. A third senior thoracic radiologist's opinion (\>20 years experience) will undertake arbitration.

The reading will be done remotely via the Report and Image Quality Control site (www.RAIQC.com), an online platform allowing medical imaging viewing and reporting. Participants can work from any location, but the work must be done from a computer with internet access. For avoidance of doubt, the work cannot be performed from a phone or tablet.

The project is divided into two phases and participants are required to complete both phases. The estimated total involvement in the project is up to 20-24 hours.

Phase 1: Time allowed: 2 weeks

- Review 500 chest X-rays and express a clinical opinion through a structured reporting template (multiple choice, no open text required).

Rest/washout period of 2 weeks.

Phase 2 - Time allowed: 2 weeks

- Review 500 chest X-rays together with an AI report for each case and express your clinical opinion through the same structured reporting template used in Phase A.

Cases reading

Two consultant thoracic radiologists will independently review the images to establish the 'ground truth' findings on the CXRs, where a consensus is reached this will then be used as the reference standard. In the case of disagreement, a third senior thoracic radiologist's opinion (\>20 years experience) will undertake arbitration. A difficulty score will be assigned to each abnormality by the ground truthers using a 4-point Likert scale (1 being easy/obvious to 4 being hard/poorly visualised).

Ground truthing

This study has been added as a sub study to the Simulation Training for Emergency Department Imaging 2 study (ClinicalTrials.gov ID NCT05427838).

The Lunit INSIGHT CXR is a validation study that aims to assess the utility of an Artificial Intelligence-based (AI) chest X-ray (CXR) interpretation tool in assisting the diagnostic accuracy, speed, and confidence of a varied group of healthcare professionals. The study will be conducted using 500 retrospectively collected inpatient and emergency department CXRs from two United Kingdom (UK) hospital trusts. Two fellowship trained thoracic radiologists will independently review all studies to establish the ground truth reference standard. The Lunit INSIGHT CXR tool will be used to analyze each CXR, and its performance will be measured against the expert readers. The study will evaluate the utility of the algorithm in improving reader accuracy and confidence as measured by sensitivity, specificity, positive predictive value, and negative predictive value. The study will measure the performance of the algorithm against ten abnormal findings, including pulmonary nodules/mass, consolidation, pneumothorax, atelectasis, calcification, cardiomegaly, fibrosis, mediastinal widening, pleural effusion, and pneumoperitoneum. The study will involve readers from various clinical professional groups with and without the assistance of Lunit INSIGHT CXR. The study will provide evidence on the impact of AI algorithms in assisting healthcare professionals such as emergency medicine and general medicine physicians who regularly review images in their daily practice.

AI Assisted Detection of Chest X-Rays

Utility of an AI-based CXR Interpretation Tool in Assisting Diagnostic Accuracy, Speed, and Confidence of Healthcare Professionals: a Study Using 500 Retrospectively Collected Inpatient and Emergency Department CXRs From Two UK Hospital Trusts

Evaluation of the Lunit INSIGHT CXR algorithm will be performed comparing it to the reference standard in order to determine sensitivity.

Evaluation of the Lunit INSIGHT CXR algorithm will be performed comparing it to the reference standard in order to determine specificity.

Evaluation of the Lunit INSIGHT CXR algorithm will be performed comparing it to the reference standard. Continuous probability score from the algorithm will be utilized for the ROC analyses, while binary classification results with a predefined operating cut-off will be used for evaluation of sensitivity, specificity, positive predictive value, and negative predictive value.

The study will include two sessions (with and without AI overlay), with all 30 readers reviewing all 500 CXR cases each time separated by a washout period to mitigate recall bias. The cases will be randomised between the two reads and for every reader.

Mean time taken to review a scan, with vs without AI assistance.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Virtual Bronchoscopic Navigation to Increase Diagnostic Yield in Patients With Pulmonary Nodules	NCT05383105	Pulmonary Nodul...	Virtual broncho...	18 Years -	University Medical Center Groningen
Early Adjuvant Diagnosis of Pulmonary Nodules Based on CTC.	NCT06187935	Pulmonary Nodul... Pulmonary Nodul...		18 Years -	China-Japan Friendship Hospital
AI Assisted Detection of Chest X-Rays	NCT06075836	Pulmonary Nodul... Pulmonary Nodul... Pulmonary Conso... Pneumothorax Pneumothorax; A... Atelectasis Pulmonary Calci... Cardiomegaly Fibrosis Lung Pleural Effusio... Pleural Effusio... Pneumoperitoneu...	Cases reading Ground truthing	-	Oxford University Hospitals NHS Trust
Virtual Bronchoscopic Navigation to Increase Diagnostic Yield in Patients With Pulmonary Nodules	NCT05383105	Pulmonary Nodul...	Virtual broncho...	18 Years -	University Medical Center Groningen
AI Assisted Detection of Chest X-Rays	NCT06075836	Pulmonary Nodul... Pulmonary Nodul... Pulmonary Conso... Pneumothorax Pneumothorax; A... Atelectasis Pulmonary Calci... Cardiomegaly Fibrosis Lung Pleural Effusio... Pleural Effusio... Pneumoperitoneu...	Cases reading Ground truthing	-	Oxford University Hospitals NHS Trust

Spots Global Cancer Trial Database for pulmonary nodules, solitary