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Completed

NCT Number: NCT04217655

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

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Lung; Node Neoplasms Neoplasms by Site 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

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Low-dose computed tomography

Diagnostic Test

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

Standard-dose computed tomography

Diagnostic Test

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 12 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. Radiation dose

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

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

Sponsors and collaborators

Lead sponsor

Xuzhou Central Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jan 3, 2020
Registry last updated
Dec 29, 2021

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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