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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04217655
Recruitment Status : Enrolling by invitation
First Posted : January 3, 2020
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
Xuzhou Central Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lung Cancer Lung; Node Diagnostic Test: Low-dose computed tomography Diagnostic Test: Standard-dose computed tomography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Low-dose Computed Tomography-guided Core Needle Biopsy for Lung Nodules
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy CT Scans

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)




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217655


Locations
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China, Jiangsu
Xuzhou Central Hospital
Xuzhou, Jiangsu, China, 221009
Sponsors and Collaborators
Xuzhou Central Hospital
Investigators
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Principal Investigator: Xian-Chi Li, MD Xuzhou Central Hospital
Publications:
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Responsible Party: Xuzhou Central Hospital
ClinicalTrials.gov Identifier: NCT04217655    
Other Study ID Numbers: 20200102-001
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make individual participant data available.

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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