Clinical Trial: Low-dose Protocol for Computed Tomography-guided Lung Biopsy

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Low-dose Protocol for Computed Tomography-guided Lung Biopsy

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Xuzhou Central Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Diagnostic accuracy [ Time Frame: From the date of randomization until the date of first documented final diagnosis, assessed up to 24 months ]

Current Secondary Outcome: 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.


Original Secondary Outcome: Complication [ Time Frame: From the date of randomization until the date of first documented biopsy-related complication, assessed up to 1 day. ]

Information By: Xuzhou Central Hospital

Dates:
Date Received: November 17, 2016
Date Started: November 2016
Date Completion: November 2019
Last Updated: November 22, 2016
Last Verified: November 2016