Low-dose Computed Tomography-guided Core Needle Biopsy for Lung Nodules

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Low-dose Computed Tomography-guided Core Needle Biopsy for Lung Nodules

Conditions
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Lung Cancer, Lung; Node

Intervention / Treatment
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* Diagnostic Test: Low-dose computed tomography
* Diagnostic Test: Standard-dose computed tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-diagnostic lung lesions (no definitive pathological diagnosis); Lesion size between 5 and 30 mm; Solid lung lesions. Exclusion Criteria: The lesion which has been punctured previously; A lesion that had shrunk in size or a lesion with a stable size for 1 year; Severe dysfunction in heart, lung and coagulation function; Patients who refused to provide informed consent.

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation dose | Radiation dose is the radiation exposure from the computed tomography device to patients. | From the date of randomization until the date of first documented biopsy procedures, assessed up to 1 day. |