Clinical trial NCT05518669: mCBCT in Combination With ENB for the Diagnosis of PPNs
Official title: Mobile Cone-Beam CT in Combination With Electromagnetic Navigation Bronchoscopy for the Diagnosis of Peripheral Pulmonary Nodules
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Pulmonary Nodules
Lung Cancer
Keywords: Peripheral Pulmonary Nodules
Diagnosis
Mobile Cone-Beam CT
Electromagnetic Navigation Bronchoscopy
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

Eligibility 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

Primary outcomes:
measure: Diagnostic yield improvement ratio
timeFrame: Up to at least 6 months
Secondary outcomes:
measure: Pre-mCBCT navigational yield
timeFrame: Intra-procedure
measure: Post-mCBCT navigational yield
timeFrame: Intra-procedure
measure: Total radiation dose
timeFrame: Intra-procedure
measure: Fluoroscopy time
timeFrame: Intra-procedure
measure: Adjustment time
timeFrame: Intra-procedure
measure: Total operation time
timeFrame: Intra-procedure
measure: Factors affecting diagnostic yield
timeFrame: Up to at least 6 months
measure: Complication rate
timeFrame: Up to 1 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Jiayuan Sun, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.