Low-dose Computed Tomography-guided Core Needle Biopsy for Lung Nodules
|ClinicalTrials.gov Identifier: NCT04217655|
Recruitment Status : Enrolling by invitation
First Posted : January 3, 2020
Last Update Posted : July 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Lung; Node||Diagnostic Test: Low-dose computed tomography Diagnostic Test: Standard-dose computed tomography||Not Applicable|
At present, low-dose scanning protocol is widely used in computed tomography-guided interventions because these procedures usually require repeat scans, which causes more radiation exposure to the patients. Computed tomography-guided core needle biopsy is widely used in diagnosis of lung nodules with an overall diagnostic accuracy of 93%-97%. Compared with the large lung lesions, computed tomography-guided core needle biopsy for lung nodules might require more scanning to adjust the position of needle tip. Therefore, it might expose the patients to more radiation. However, studies regarding computed tomography-guided core needle biopsy for lung nodules are still lacking.
In this study, investigators aim to compare the diagnostic accuracy and radiation exposure between low-dose and standard-dose computed tomography-guided core needle biopsy for lung nodules.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Low-dose Computed Tomography-guided Core Needle Biopsy for Lung Nodules|
|Actual Study Start Date :||June 1, 2020|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Low-dose computed tomography group
Patients undergo low-dose computed tomography-guided lung biopsy for lung nodule on day 1.
Diagnostic Test: Low-dose computed tomography
Radiation dose under the low-dose protocol computed tomography (120 kilovolt, 15 milliampere seconds)
Active Comparator: Standard-dose computed tomography group
Patients undergo standard-dose computed tomography-guided lung biopsy for lung nodule on day 1.
Diagnostic Test: Standard-dose computed tomography
Radiation dose under the standard-dose protocol computed tomography (120 kilovolt, 150 milliampere seconds)
- Diagnostic accuracy [ Time Frame: From the date of randomization until the date of first documented final diagnosis, assessed up to 12 months ]Diagnostic accuracy is defined as the biopsy diagnosis matches with the final diagnosis. The final diagnosis is made according to the surgical or follow-up findings.
- Radiation dose [ Time Frame: From the date of randomization until the date of first documented biopsy procedures, assessed up to 1 day. ]Radiation dose is the radiation exposure from the computed tomography device to patients.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217655
|Xuzhou Central Hospital|
|Xuzhou, Jiangsu, China, 221009|
|Principal Investigator:||Xian-Chi Li, MD||Xuzhou Central Hospital|