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Trial Title:
mCBCT in Combination With ENB for the Diagnosis of PPNs
NCT ID:
NCT05518669
Condition:
Peripheral Pulmonary Nodules
Lung Cancer
Conditions: Official terms:
Multiple Pulmonary Nodules
Conditions: Keywords:
Peripheral Pulmonary Nodules
Diagnosis
Mobile Cone-Beam CT
Electromagnetic Navigation Bronchoscopy
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
Electromagnetic Navigation Bronchoscopy (superDimension™ Navigation System) and Mobile Cone-Beam CT (Cios Spin)
Description:
Subjects with biopsy of peripheral pulmonary nodule using electromagnetic navigation
bronchoscopy and mobile cone-beam CT.
Arm group label:
Peripheral Pulmonary Nodules
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Zip:
200030
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiayuan Sun, MD
Email:
jysun1976@163.com
Investigator:
Last name:
Jiayuan Sun, MD
Email:
Principal Investigator
Start date:
September 26, 2022
Completion date:
June 30, 2024
Lead sponsor:
Agency:
Shanghai Chest Hospital
Agency class:
Other
Source:
Shanghai Chest Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05518669