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

Not Applicable

Completed

• Conditions: Lung; Node; Lung Cancer
• Interventions: Diagnostic Test: Standard-dose computed tomography; Diagnostic Test: Low-dose computed tomography

• Registration Number: NCT04217655
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2020-01-01
• Study First Submitted QC: 2020-01-01
• Study First Posted: 2020-01-03
• Study Start: 2020-06-01
• Primary Completion: 2020-12-31
• Status Verified: 2021-12
• Study Completion: 2021-12-28
• Last Update Submitted: 2021-12-28
• Last Update Posted: 2021-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard-dose computed tomography group	Standard-dose computed tomography	Patients undergo standard-dose computed tomography-guided lung biopsy for lung nodule on day 1.
Low-dose computed tomography group	Low-dose computed tomography	Patients undergo low-dose computed tomography-guided lung biopsy for lung nodule on day 1.

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy	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

Name	Time	Method
Radiation dose	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.

Trial Locations

Locations (1)

Xuzhou Central Hospital; 🇨🇳 Xuzhou, Jiangsu, China