To hear about similar clinical trials, please enter your email below

Trial Title: mCBCT in Combination With ENB for the Diagnosis of PPNs

NCT ID: NCT05518669

Condition: Peripheral Pulmonary Nodules
Lung Cancer

Conditions: Official terms:
Multiple Pulmonary Nodules

Conditions: Keywords:
Peripheral Pulmonary Nodules
Diagnosis
Mobile Cone-Beam CT
Electromagnetic Navigation Bronchoscopy

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Device
Intervention name: Electromagnetic Navigation Bronchoscopy (superDimension™ Navigation System) and Mobile Cone-Beam CT (Cios Spin)
Description: Subjects with biopsy of peripheral pulmonary nodule using electromagnetic navigation bronchoscopy and mobile cone-beam CT.
Arm group label: Peripheral Pulmonary Nodules

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.

Criteria for eligibility:

Study pop:
Patients with the presence of pulmonary peripheral nodules on chest CT imaging suspicion of malignancy that need to obtain pathologic diagnosis by transbronchial lung biopsy.

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Shanghai Chest Hospital

Address:
City: Shanghai
Zip: 200030
Country: China

Status: Recruiting

Contact:
Last name: Jiayuan Sun, MD
Email: jysun1976@163.com

Investigator:
Last name: Jiayuan Sun, MD
Email: Principal Investigator

Start date: September 26, 2022

Completion date: June 30, 2024

Lead sponsor:
Agency: Shanghai Chest Hospital
Agency class: Other

Source: Shanghai Chest Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05518669

Login to your account

Did you forget your password?