Low-dose Computed Tomography-guided Core Needle Biopsy for Lung Nodules
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Jiangsu
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Xuzhou, Jiangsu, China, 221009
- Xuzhou Central Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Non-diagnostic lung lesions (no definitive pathological diagnosis);
- Lesion size between 5 and 30 mm;
- Solid lung lesions.
Exclusion Criteria:
- The lesion which has been punctured previously;
- A lesion that had shrunk in size or a lesion with a stable size for 1 year;
- Severe dysfunction in heart, lung and coagulation function;
- Patients who refused to provide informed consent.
Study Plan
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.
|
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.
|
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
Sponsor
Investigators
- Principal Investigator: Xian-Chi Li, MD, Xuzhou Central Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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