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Completed

NCT Number: NCT02971176

Low-dose Protocol for Computed Tomography-guided Lung Biopsy

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.

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Key information

Conditions

Lung Cancer, Adenocarcinoma Adenocarcinoma Adenocarcinoma of Lung Carcinoma Lung Diseases Lung Inflammatory Pseudotumor Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Plasma Cell Granuloma, Pulmonary Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuzhou Central Hospital

Xuzhou, Jiangsu, 221009, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low-dose protocol computed tomography

Radiation

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

Standard-dose protocol computed tomography

Radiation

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

Primary outcomes

  1. Diagnostic accuracy

    Time frame: From the date of randomization until the date of first documented final diagnosis, assessed up to 24 months

    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.

Secondary outcomes

  1. Complication

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

    Biopsy-related complications mainly include pneumothorax and hemoptysis. Complications is evaluated by computed tomography scan and clinical symptoms.

Sponsors and collaborators

Lead sponsor

Xuzhou Central Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 22, 2016
Registry last updated
Jun 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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