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

Xuzhou Central Hospital200 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

200

Conditions

Lung Cancer Lung; Node

Interventions

Low-dose computed tomographyDIAGNOSTIC_TEST

Radiation dose under the low-dose protocol computed tomography (120 kilovolt, 15 milliampere seconds)

Standard-dose computed tomographyDIAGNOSTIC_TEST

Radiation dose under the standard-dose protocol computed tomography (120 kilovolt, 150 milliampere seconds)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Non-diagnostic lung lesions (no definitive pathological diagnosis); 2. Lesion size between 5 and 30 mm; 3. Solid lung lesions. Exclusion Criteria: 1. The lesion which has been punctured previously; 2. A lesion that had shrunk in size or a lesion with a stable size for 1 year; 3. Severe dysfunction in heart, lung and coagulation function; 4. Patients who refused to provide informed consent.

Locations (1)

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Outcomes

Primary Outcomes

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.

Time frame: From the date of randomization until the date of first documented final diagnosis, assessed up to 12 months

Secondary Outcomes

Radiation dose

Radiation dose is the radiation exposure from the computed tomography device to patients.

Time frame: From the date of randomization until the date of first documented biopsy procedures, assessed up to 1 day.

Data from ClinicalTrials.gov

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