Low-dose Protocol for Computed Tomography-guided Lung Biopsy

Study Overview
=================
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 Description
-----------------
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.

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

Conditions
-----------------
Lung Cancer, Adenocarcinoma, Lung Inflammatory Pseudotumor

Intervention / Treatment
-----------------
* Radiation: Low-dose protocol computed tomography
* Radiation: Standard-dose protocol computed tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-diagnostic lung lesions; Solid lung lesions; Lesion size ≥ 5mm. Exclusion Criteria: The lesion which has been punctured previously; Severe dysfunction in heart, lung and coagulation function.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-dose protocol<br>Patients undergo low-dose protocol computed tomography-guided lung biopsy on day 1. | Radiation: Low-dose protocol computed tomography<br>* Radiation dose under the low-dose protocol computed tomography (120 kilovolt, 15 milliampere seconds)<br>|
| Active Comparator: Standard-dose protocol<br>Patients undergo standard-dose protocol computed tomography-guided lung biopsy on day 1. | Radiation: Standard-dose protocol computed tomography<br>* Radiation dose under the standard-dose protocol computed tomography (120 kilovolt, 150 milliampere seconds)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy | 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. | From the date of randomization until the date of first documented final diagnosis, assessed up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication | Biopsy-related complications mainly include pneumothorax and hemoptysis. Complications is evaluated by computed tomography scan and clinical symptoms. | From the date of randomization until the date of first documented biopsy-related complication, assessed up to 1 day. |