Clinical trial · Observational
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
NCT05518669CI-TRIAL-00069523unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Peripheral Pulmonary Nodules | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electromagnetic Navigation Bronchoscopy (superDimension™ Navigation System) and Mobile Cone-Beam CT (Cios Spin) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Device: Electromagnetic Navigation Bronchoscopy (superDimension™ Navigation System) and Mobile Cone-Beam CT (Cios Spin)
Primary outcomes (1)
- measure
- Diagnostic yield improvement ratio
- timeFrame
- Up to at least 6 months
- description
- 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.
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDCasal 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. PMID 30746241
- BACKGROUNDReisenauer 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. PMID 35509435
- BACKGROUNDHsieh 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. PMID 34291295
- BACKGROUNDChen 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. PMID 34430367