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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer; Peripheral Pulmonary Nodules
• Intervention / Treatment: Device: Electromagnetic Navigation Bronchoscopy (superDimension™ Navigation System) and Mobile Cone-Beam CT (Cios Spin)

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.

• Study Type: Observational
• Enrollment (Estimated): 109

Contacts and Locations

• Study Contact: Name: Jiayuan Sun, MD, PhD; Phone Number: 1511 86-21-22200000; Email: jysun1976@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shanghai Chest Hospital
      • Contact: Jiayuan Sun, MD; Email: jysun1976@163.com
      • Principal Investigator: Jiayuan Sun, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Peripheral Pulmonary Nodules; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Fluoroscopy time	The fluoroscopy time during the procedure.	Intra-procedure
Adjustment time	The adjustment time during the procedure, defined as the time between the first mCBCT spin scanning to final spin scanning.	Intra-procedure
Total operation time	The total operation time was defined as the time from bronchoscope insertion to withdrawal of the glottis.	Intra-procedure
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
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

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital
• Investigators: Principal Investigator: Jiayuan Sun, MD,PhD, Shanghai Chest Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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;:
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Diagnosis; Peripheral Pulmonary Nodules; Electromagnetic Navigation Bronchoscopy; Mobile Cone-Beam CT
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules
• Other Study ID Numbers: SHCHE202207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No