Low-dose Protocol for Computed Tomography-guided Lung Biopsy

Not Applicable

Completed

• Conditions: Lung Cancer, Adenocarcinoma; Lung Inflammatory Pseudotumor
• Interventions: Radiation: Standard-dose protocol computed tomography; Radiation: Low-dose protocol computed tomography

• Registration Number: NCT02971176
• Lead Sponsor: Xuzhou Central Hospital

Brief Summary

The purpose of this study is to compare the diagnostic accuracy and complication rate between low-dose computed tomography-guided and standard-dose computed tomography-guided lung biopsy.

Detailed Description

With the comprehensive usage of computed tomography examination, patients are more and more aware of the radiation dose of computed tomography. Concerns over the potential for radiation induced malignancies have increasingly been published in the scientific literature and reported in the popular press. The risk is highest for younger patients, who have more radiation-sensitive tissues and longer life expectancies than adults. Recently, the United States Food and Drug Administration announced an initiative to reduce unnecessary radiation exposure from medical imaging. At present, low-dose computed tomography protocol is widely used for the diagnosis of cardiovascular and cerebrovascular diseases.

Computed tomography-guided lung biopsy is widely used for diagnosis of lung nodules and masses. However, it requires repeating scanning to guide the needles, which inevitably increases the radiation dose. Therefore, low-dose protocol was also used in the computed tomography-guided lung biopsy procedure.

The purpose of this study is to compare the diagnostic accuracy and complication rate between low-dose computed tomography-guided and standard-dose computed tomography-guided lung biopsy.

Study Timeline

• Study First Submitted: 2016-11-17
• Study First Submitted QC: 2016-11-17
• Study First Posted: 2016-11-22
• Study Start: 2016-11-30
• Primary Completion: 2019-05-31
• Study Completion: 2019-05-31
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-02
• Last Update Posted: 2019-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

• Non-diagnostic lung lesions; Solid lung lesions; Lesion size ≥ 5mm.

Exclusion Criteria

• The lesion which has been punctured previously; Severe dysfunction in heart, lung and coagulation function.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard-dose protocol	Standard-dose protocol computed tomography	Patients undergo standard-dose protocol computed tomography-guided lung biopsy on day 1.
Low-dose protocol	Low-dose protocol computed tomography	Patients undergo low-dose protocol computed tomography-guided lung biopsy 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 24 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
Complication	From the date of randomization until the date of first documented biopsy-related complication, assessed up to 1 day.	Biopsy-related complications mainly include pneumothorax and hemoptysis. Complications is evaluated by computed tomography scan and clinical symptoms.

Trial Locations

Locations (1)

Xuzhou Central Hospital; 🇨🇳 Xuzhou, Jiangsu, China