mCBCT in Combination With ENB for the Diagnosis of PPNs

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05518669
• Other study ID #: SHCHE202207
• Status: Recruiting
• Start date: September 26, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2023
• Source: Shanghai Chest Hospital
• Contact: Jiayuan Sun, MD, PhD
• Phone: 86-21-22200000
• Email: jysun1976[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 109
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Multiple Pulmonary Nodules
• Peripheral Pulmonary Nodules

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

Casal RF, Sarkiss M, Jones AK, Stewart J, Tam A, Grosu HB, Ost DE, Jimenez CA, Eapen GA. Cone beam computed tomography-guided thin/ultrathin bronchoscopy for diagnosis of peripheral lung nodules: a prospective pilot study. J Thorac Dis. 2018 Dec;10(12):6950-6959. doi: 10.21037/jtd.2018.11.21. — View Citation

Chen J, Xie F, Zheng X, Li Y, Liu S, Ma KC, Goto T, Muller T, Chan ED, Sun J. Mobile 3-dimensional (3D) C-arm system-assisted transbronchial biopsy and ablation for ground-glass opacity pulmonary nodules: a case report. Transl Lung Cancer Res. 2021 Jul;10(7):3312-3319. doi: 10.21037/tlcr-21-561. — View Citation

Hsieh MJ, Chou PL, Fang HY, Wen CT, Chao YK. Single-step localization and excision of small pulmonary nodules using a mobile 3D C-arm. Interact Cardiovasc Thorac Surg. 2021 Nov 22;33(6):885-891. doi: 10.1093/icvts/ivab182. Erratum In: Interact Cardiovasc Thorac Surg. 2021 Sep 14;: — View Citation

Reisenauer J, Duke JD, Kern R, Fernandez-Bussy S, Edell E. Combining Shape-Sensing Robotic Bronchoscopy With Mobile Three-Dimensional Imaging to Verify Tool-in-Lesion and Overcome Divergence: A Pilot Study. Mayo Clin Proc Innov Qual Outcomes. 2022 Apr 23;6(3):177-185. doi: 10.1016/j.mayocpiqo.2022.02.004. eCollection 2022 Jun. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic yield improvement ratio	Diagnostic yield improvement ratio, defined as Post-mCBCT diagnostic yield minus Pre-mCBCT diagnostic yield.; The Pre-mCBCT diagnostic yield, defined as the proportion of patients diagnosed by electromagnetic navigation bronchoscopy and without any adjustment after first time mCBCT spin during the procedure in all enrolled subjects.; The Post-mCBCT diagnostic yield, defined as the proportion of diagnosed patients including those with and without adjustment after mCBCT spin in all enrolled subjects.; Diagnostic yield was defined as all instances in which the results of bronchoscopy matched the final diagnoses.	Up to at least 6 months
Secondary	Pre-mCBCT navigational yield	The proportion of patients who was confirmed tool-in-lesion by the first time mCBCT spin and no need for further adjustment in all enrolled subjects.	Intra-procedure
Secondary	Post-mCBCT navigational yield	The proportion of patients who was confirmed tool-in-lesion with and without adjustment by mCBCT in all enrolled subjects.	Intra-procedure
Secondary	Total radiation dose	Radiation dose from procedure, measured by the dose area product (DAP), defined as the product of dose and beam area (Gy cm^2).	Intra-procedure
Secondary	Fluoroscopy time	The fluoroscopy time during the procedure.	Intra-procedure
Secondary	Adjustment time	The adjustment time during the procedure, defined as the time between the first mCBCT spin scanning to final spin scanning.	Intra-procedure
Secondary	Total operation time	The total operation time was defined as the time from bronchoscope insertion to withdrawal of the glottis.	Intra-procedure
Secondary	Factors affecting diagnostic yield	The factors affecting diagnostic yield includes the nodule nature, nodule size, nodule location, bronchus sign on CT, etc.	Up to at least 6 months
Secondary	Complication rate	The complications refer to the proportion of serious adverse events related to the procedure during or within 1 month after the operation.	Up to 1 month