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

December 28, 2021 updated by: Xuzhou Central Hospital
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221009
        • Xuzhou Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low-dose computed tomography group
Patients undergo low-dose computed tomography-guided lung biopsy for lung nodule on day 1.
Diagnostic test: Low-dose computed tomography
Radiation dose under the low-dose protocol computed tomography (120 kilovolt, 15 milliampere seconds)
Active Comparator: Standard-dose computed tomography group
Patients undergo standard-dose computed tomography-guided lung biopsy for lung nodule on day 1.
Diagnostic test: Standard-dose computed tomography
Radiation dose under the standard-dose protocol computed tomography (120 kilovolt, 150 milliampere seconds)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the date of randomization until the date of first documented final diagnosis, assessed up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the date of randomization until the date of first documented biopsy procedures, assessed up to 1 day.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuzhou Central Hospital

Investigators

  • Principal Investigator: Xian-Chi Li, MD, Xuzhou Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 28, 2021

Study Registration Dates

First Submitted

January 1, 2020

First Submitted That Met QC Criteria

January 1, 2020

First Posted (Actual)

January 3, 2020

Study Record Updates

Last Update Posted (Actual)

December 29, 2021

Last Update Submitted That Met QC Criteria

December 28, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 20200102-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make individual participant data available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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