mCBCT in Combination With ENB for the Diagnosis of PPNs

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Lung Cancer; Peripheral Pulmonary Nodules

Treatments: Device: Electromagnetic Navigation Bronchoscopy (superDimension™ Navigation System) and Mobile Cone-Beam CT (Cios Spin)

Study type: Observational

Funder types: Other

Identifiers

NCT05518669

SHCHE202207

Details and patient eligibility

About

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.

Full 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.

Enrollment: 109 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

109 participants in 1 patient group

Peripheral Pulmonary Nodules

Description:

Patients with peripheral pulmonary nodules on chest computed tomography suspicion of malignancy who are scheduled to reach the target lesion for diagnosis by mobile cone-beam CT combined with electromagnetic navigation bronchoscopy.

Treatment:

Device: Electromagnetic Navigation Bronchoscopy (superDimension™ Navigation System) and Mobile Cone-Beam CT (Cios Spin)