Lung Cancer Clinical Trial
Official title:
Low-dose Computed Tomography-guided Core Needle Biopsy for Lung Nodules
Verified date | December 2021 |
Source | Xuzhou Central Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | December 28, 2021 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Xuzhou Central Hospital | Xuzhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Xuzhou Central Hospital |
China,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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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