Low-dose Protocol for Computed Tomography-guided Lung Biopsy
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|ClinicalTrials.gov Identifier: NCT02971176|
Recruitment Status : Completed
First Posted : November 22, 2016
Last Update Posted : June 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer, Adenocarcinoma Lung Inflammatory Pseudotumor||Radiation: Low-dose protocol computed tomography Radiation: Standard-dose protocol computed tomography||Not Applicable|
With the comprehensive usage of computed tomography examination, patients are more and more aware of the radiation dose of computed tomography. Concerns over the potential for radiation induced malignancies have increasingly been published in the scientific literature and reported in the popular press. The risk is highest for younger patients, who have more radiation-sensitive tissues and longer life expectancies than adults. Recently, the United States Food and Drug Administration announced an initiative to reduce unnecessary radiation exposure from medical imaging. At present, low-dose computed tomography protocol is widely used for the diagnosis of cardiovascular and cerebrovascular diseases.
Computed tomography-guided lung biopsy is widely used for diagnosis of lung nodules and masses. However, it requires repeating scanning to guide the needles, which inevitably increases the radiation dose. Therefore, low-dose protocol was also used in the computed tomography-guided lung biopsy procedure.
The purpose of this study is to compare the diagnostic accuracy and complication rate between low-dose computed tomography-guided and standard-dose computed tomography-guided lung biopsy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||280 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Low-dose Protocol for Computed Tomography-guided Lung Biopsy|
|Actual Study Start Date :||November 30, 2016|
|Actual Primary Completion Date :||May 31, 2019|
|Actual Study Completion Date :||May 31, 2019|
Experimental: Low-dose protocol
Patients undergo low-dose protocol computed tomography-guided lung biopsy on day 1.
Radiation: Low-dose protocol computed tomography
Radiation dose under the low-dose protocol computed tomography (120 kilovolt, 15 milliampere seconds)
Active Comparator: Standard-dose protocol
Patients undergo standard-dose protocol computed tomography-guided lung biopsy on day 1.
Radiation: Standard-dose protocol 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 24 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.
- Complication [ Time Frame: From the date of randomization until the date of first documented biopsy-related complication, assessed up to 1 day. ]Biopsy-related complications mainly include pneumothorax and hemoptysis. Complications is evaluated by computed tomography scan and clinical symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02971176
|Xuzhou Central Hospital|
|Xuzhou, Jiangsu, China, 221009|
|Principal Investigator:||Zi-Qi Tao, MD||Science and Education Division of Xuzhou Central Hospital|