NCT05518669

mCBCT in Combination With ENB for the Diagnosis of PPNs

Mobile Cone-Beam CT in Combination With Electromagnetic Navigation Bronchoscopy for the Diagnosis of Peripheral Pulmonary Nodules

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 109 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the clinical value of mobile cone-beam CT (mCBCT) in combination with electromagnetic navigation bronchoscopy for the diagnosis of peripheral pulmonary nodules, and to explore the value of mCBCT in improving the diagnostic yield by calculating the improvement in diagnostic yield of patients before and after mCBCT adjustments.

Detailed description

This study is a prospective, single-arm, single-center observational clinical trial to evaluate the diagnostic value of mobile cone-beam CT (mCBCT) in combination with electromagnetic navigation bronchoscopy for the diagnosis of peripheral pulmonary nodules. The investigators will adjust the position of electromagnetic navigation bronchoscopy base on the intraoperative 3D imaging findings of mCBCT. The value of mCBCT in improving diagnostic yield is explored by comparing the diagnostic yield Post-mCBCT with that of Pre-mCBCT. The Pre-mCBCT diagnostic yield is the proportion of patients diagnosed by electromagnetic navigation bronchoscopy and with no need for adjustment after mCBCT spin confirmed "tool-in-lesion" during the procedure in all enrolled subjects. The Post-mCBCT diagnostic yield is the proportion of diagnosed patients with and without adjustment after mCBCT spin during the procedure in all enrolled subjects.

Conditions

• Peripheral Pulmonary Nodules
• Lung Cancer

Interventions

Type	Name	Description
DEVICE	Electromagnetic Navigation Bronchoscopy (superDimension™ Navigation System) and Mobile Cone-Beam CT (Cios Spin)	Subjects with biopsy of peripheral pulmonary nodule using electromagnetic navigation bronchoscopy and mobile cone-beam CT.

Timeline

• Start date: 2022-09-26
• Primary completion: 2023-12-31
• Completion: 2024-06-30
• First posted: 2022-08-26
• Last updated: 2023-09-13

Locations

1 site across 1 country: China