Low-dose Computed Tomography-guided Core Needle Biopsy for Lung Nodules

Lung Cancer Clinical Trial

Official title:

Low-dose Computed Tomography-guided Core Needle Biopsy for Lung Nodules

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04217655
• Other study ID #: 20200102-001
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung; Node

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.