Low-dose Protocol for Computed Tomography-guided Lung Biopsy

Xuzhou Central Hospital (Xuzhou Fourth People's Hospital)

Status: Completed

Conditions: Lung Cancer, Adenocarcinoma; Lung Inflammatory Pseudotumor

Treatments: Radiation: Standard-dose protocol computed tomography; Radiation: Low-dose protocol computed tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT02971176

20161115-010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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280 participants in 2 patient groups

Low-dose protocol

Experimental group

Description:

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

Treatment:

Radiation: Low-dose protocol computed tomography

Standard-dose protocol

Active Comparator group

Description:

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

Treatment:

Radiation: Standard-dose protocol computed tomography