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

Xuzhou Central Hospital (Xuzhou Fourth People's Hospital)

Status: Completed

Conditions: Lung; Node; Lung Cancer

Treatments: Diagnostic Test: Standard-dose computed tomography; Diagnostic Test: Low-dose computed tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT04217655

20200102-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Low-dose computed tomography group

Experimental group

Description:

Patients undergo low-dose computed tomography-guided lung biopsy for lung nodule on day 1.

Treatment:

Diagnostic Test: Low-dose computed tomography

Standard-dose computed tomography group

Active Comparator group

Description:

Patients undergo standard-dose computed tomography-guided lung biopsy for lung nodule on day 1.

Treatment:

Diagnostic Test: Standard-dose computed tomography