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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose computed tomography group | Experimental | Patients undergo low-dose computed tomography-guided lung biopsy for lung nodule on day 1. |
|
| Standard-dose computed tomography group | Active Comparator | Patients undergo standard-dose computed tomography-guided lung biopsy for lung nodule on day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-dose computed tomography | Diagnostic Test | Radiation dose under the low-dose protocol computed tomography (120 kilovolt, 15 milliampere seconds) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Radiation dose | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xian-Chi Li, MD | Xuzhou Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuzhou Central Hospital | Xuzhou | Jiangsu | 221009 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31776740 | Background | 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. | |
| 36927419 | Derived | Li EL, Ma AL, Wang T, Fu YF, Liu HY, Li GC. Low-dose versus standard-dose computed tomography-guided biopsy for pulmonary nodules: a randomized controlled trial. J Cardiothorac Surg. 2023 Mar 16;18(1):86. doi: 10.1186/s13019-023-02183-8. |
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There is not a plan to make individual participant data available.
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D014057 | Tomography, X-Ray Computed |
| ID | Term |
|---|---|
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Standard-dose computed tomography | Diagnostic Test | Radiation dose under the standard-dose protocol computed tomography (120 kilovolt, 150 milliampere seconds) |
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D014054 | Tomography |