mCBCT in Combination With ENB for the Diagnosis of PPNs
September 7, 2023 updated by: Jiayuan Sun, Shanghai Chest Hospital
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
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jiayuan Sun, MD, PhD
- Phone Number: 1511 86-21-22200000
- Email: jysun1976@163.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200030
- Recruiting
- Shanghai Chest Hospital
-
Contact:
- Jiayuan Sun, MD
- Email: jysun1976@163.com
-
Principal Investigator:
- Jiayuan Sun, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
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.
|
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
Time Frame: Up to at least 6 months
|
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
Time Frame: Intra-procedure
|
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
Time Frame: Intra-procedure
|
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
Time Frame: Intra-procedure
|
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
Time Frame: Intra-procedure
|
The fluoroscopy time during the procedure.
|
Intra-procedure
|
|
Adjustment time
Time Frame: Intra-procedure
|
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
Time Frame: Intra-procedure
|
The total operation time was defined as the time from bronchoscope insertion to withdrawal of the glottis.
|
Intra-procedure
|
|
Factors affecting diagnostic yield
Time Frame: Up to at least 6 months
|
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
Time Frame: Up to 1 month
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jiayuan Sun, MD,PhD, Shanghai Chest Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
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