Using mobile CT and navigation bronchoscopy to diagnose lung nodules
Mobile Cone-Beam CT in Combination With Electromagnetic Navigation Bronchoscopy for the Diagnosis of Peripheral Pulmonary Nodules
This study is testing if using a special mobile imaging tool with bronchoscopy can help doctors better diagnose lung nodules in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 109 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Chest Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT05518669 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of mobile cone-beam CT (mCBCT) combined with electromagnetic navigation bronchoscopy for diagnosing peripheral pulmonary nodules. The approach involves adjusting the bronchoscopy position based on real-time 3D imaging from mCBCT to enhance diagnostic accuracy. The study compares the diagnostic yield before and after the use of mCBCT to determine its impact on patient outcomes. It is a single-center trial conducted at Shanghai Chest Hospital.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with peripheral pulmonary nodules greater than 8mm and up to 30mm, suspected of malignancy.
Not a fit: Patients with severe cardiopulmonary dysfunction or those with other contraindications for bronchoscopy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the accuracy of diagnosing lung cancer in patients with peripheral pulmonary nodules.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving diagnostic yields for lung nodules using advanced imaging techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject with age of 18 years and older * Chest CT imaging shows the presence of peripheral pulmonary nodules (defined as those lesions that are surrounded by pulmonary parenchyma and located below the segmental bronchus) suspicion of malignancy that need to be confirmed by pathology * Pulmonary nodules of \> 8mm and ≤30 mm in largest dimension * Patients without contraindications of bronchoscopy * Patients have good medical adherence and signed informed consent Exclusion Criteria: * Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy * Presence of concomitant endobronchial lesion during the bronchoscopy procedure * Pre-operative mCBCT spin scan showed no visible lesions
Where this trial is running
Shanghai, Shanghai
- Shanghai Chest Hospital — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Jiayuan Sun, MD,PhD — Shanghai Chest Hospital
- Study coordinator: Jiayuan Sun, MD, PhD
- Email: jysun1976@163.com
- Phone: 86-21-22200000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.