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

NCT04217655 | Completed DMC

• 1 other identifier: 20200102-001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer; Lung; Node

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Radiation dose

  From the date of randomization until the date of first documented biopsy procedures, assessed up to 1 day.

Study Arms (2)

Low-dose computed tomography group

EXPERIMENTAL

Patients undergo low-dose computed tomography-guided lung biopsy for lung nodule on day 1.

Diagnostic Test: Low-dose computed tomography

Standard-dose computed tomography group

ACTIVE COMPARATOR

Patients undergo standard-dose computed tomography-guided lung biopsy for lung nodule on day 1.

Diagnostic Test: Standard-dose computed tomography

Interventions

Low-dose computed tomography DIAGNOSTIC_TEST

Radiation dose under the low-dose protocol computed tomography (120 kilovolt, 15 milliampere seconds)

Low-dose computed tomography group

Standard-dose computed tomography DIAGNOSTIC_TEST

Radiation dose under the standard-dose protocol computed tomography (120 kilovolt, 150 milliampere seconds)

Standard-dose computed tomography group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-diagnostic lung lesions (no definitive pathological diagnosis);
• Lesion size between 5 and 30 mm;
• Solid lung lesions.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuzhou Central Hospital: lead

Study Sites (1)

Xuzhou Central Hospital

Xuzhou, Jiangsu, 221009, China

Location

Related Publications (2)

• 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.

  PMID: 31776740 BACKGROUND

• 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.

  PMID: 36927419 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Xian-Chi Li, MD

  Xuzhou Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2020
• First Posted: January 3, 2020
• Study Start: June 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 28, 2021
• Last Updated: December 29, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)