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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04217655
Other study ID # 20200102-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2020
Est. completion date December 28, 2021

Study information

Verified date December 2021
Source Xuzhou Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Low-dose computed tomography
Radiation dose under the low-dose protocol computed tomography (120 kilovolt, 15 milliampere seconds)
Standard-dose computed tomography
Radiation dose under the standard-dose protocol computed tomography (120 kilovolt, 150 milliampere seconds)

Locations

Country Name City State
China Xuzhou Central Hospital Xuzhou Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Xuzhou Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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

Outcome

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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