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

NCT ID: NCT04217655

Last Updated: 2021-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-12-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lung Cancer Lung; Node

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Low-dose computed tomography group

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

Group Type EXPERIMENTAL

Low-dose computed tomography

Intervention Type DIAGNOSTIC_TEST

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

Standard-dose computed tomography group

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

Group Type ACTIVE_COMPARATOR

Standard-dose computed tomography

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Low-dose computed tomography

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

Intervention Type DIAGNOSTIC_TEST

Standard-dose computed tomography

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuzhou Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xian-Chi Li, MD

Role: PRINCIPAL_INVESTIGATOR

Xuzhou Central Hospital

Locations

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Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 31776740 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36927419 (View on PubMed)

Other Identifiers

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20200102-001

Identifier Type: -

Identifier Source: org_study_id