mCBCT in Combination With ENB for the Diagnosis of PPNs

NCT05518669 | Unknown DMC

• 1 other identifier: SHCHE202207
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Pulmonary Nodules; Lung Cancer

Keywords

Peripheral Pulmonary Nodules; Diagnosis; Mobile Cone-Beam CT; Electromagnetic Navigation Bronchoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Pre-mCBCT navigational yield

  Intra-procedure

• Post-mCBCT navigational yield

  Intra-procedure

• Total radiation dose

  Intra-procedure

• Fluoroscopy time

  Intra-procedure

• Adjustment time

  Intra-procedure

Study Arms (1)

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)

Interventions

Electromagnetic Navigation Bronchoscopy (superDimension™ Navigation System) and Mobile Cone-Beam CT (Cios Spin) DEVICE

Subjects with biopsy of peripheral pulmonary nodule using electromagnetic navigation bronchoscopy and mobile cone-beam CT.

Peripheral Pulmonary Nodules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Related 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.

  PMID: 30746241 BACKGROUND

• 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.

  PMID: 35509435 BACKGROUND

• 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.

  PMID: 34291295 BACKGROUND

• 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.

  PMID: 34430367 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Disease

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jiayuan Sun, MD,PhD

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiayuan Sun, MD, PhD

CONTACT

86-21-22200000; jysun1976@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Respiratory Endoscopy, Shanghai Chest Hospital

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 26, 2022
• Study Start: September 26, 2022
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)