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

Overview

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 31, 2020

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.

Interventions

  • Diagnostic Test: Low-dose computed tomography
    • Radiation dose under the low-dose protocol computed tomography (120 kilovolt, 15 milliampere seconds)
  • Diagnostic Test: Standard-dose computed tomography
    • Radiation dose under the standard-dose protocol computed tomography (120 kilovolt, 150 milliampere seconds)

Arms, Groups and Cohorts

  • Experimental: Low-dose computed tomography group
    • Patients undergo low-dose computed tomography-guided lung biopsy for lung nodule on day 1.
  • Active Comparator: Standard-dose computed tomography group
    • Patients undergo standard-dose computed tomography-guided lung biopsy for lung nodule on day 1.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Xuzhou Central Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Xian-Chi Li, MD, Principal Investigator, Xuzhou Central Hospital

References

Fu YF, Li GC, Xu QS, Shi YB, Wang C, Wang T. Computed tomography-guided lung biopsy: a randomized controlled trial of low-dose versus standard-dose protocol. Eur Radiol. 2020 Mar;30(3):1584-1592. doi: 10.1007/s00330-019-06464-6. Epub 2019 Nov 27.

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