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Low-dose Protocol for Computed Tomography-guided Lung Biopsy

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ClinicalTrials.gov Identifier: NCT02971176
Recruitment Status : Completed
First Posted : November 22, 2016
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Xuzhou Central Hospital

Brief Summary:
The purpose of this study is to compare the diagnostic accuracy and complication rate between low-dose computed tomography-guided and standard-dose computed tomography-guided lung biopsy.

Condition or disease Intervention/treatment Phase
Lung Cancer, Adenocarcinoma Lung Inflammatory Pseudotumor Radiation: Low-dose protocol computed tomography Radiation: Standard-dose protocol computed tomography Not Applicable

Detailed Description:

With the comprehensive usage of computed tomography examination, patients are more and more aware of the radiation dose of computed tomography. Concerns over the potential for radiation induced malignancies have increasingly been published in the scientific literature and reported in the popular press. The risk is highest for younger patients, who have more radiation-sensitive tissues and longer life expectancies than adults. Recently, the United States Food and Drug Administration announced an initiative to reduce unnecessary radiation exposure from medical imaging. At present, low-dose computed tomography protocol is widely used for the diagnosis of cardiovascular and cerebrovascular diseases.

Computed tomography-guided lung biopsy is widely used for diagnosis of lung nodules and masses. However, it requires repeating scanning to guide the needles, which inevitably increases the radiation dose. Therefore, low-dose protocol was also used in the computed tomography-guided lung biopsy procedure.

The purpose of this study is to compare the diagnostic accuracy and complication rate between low-dose computed tomography-guided and standard-dose computed tomography-guided lung biopsy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Low-dose Protocol for Computed Tomography-guided Lung Biopsy
Actual Study Start Date : November 30, 2016
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : May 31, 2019


Arm Intervention/treatment
Experimental: Low-dose protocol
Patients undergo low-dose protocol computed tomography-guided lung biopsy on day 1.
Radiation: Low-dose protocol computed tomography
Radiation dose under the low-dose protocol computed tomography (120 kilovolt, 15 milliampere seconds)

Active Comparator: Standard-dose protocol
Patients undergo standard-dose protocol computed tomography-guided lung biopsy on day 1.
Radiation: Standard-dose protocol computed tomography
Radiation dose under the standard-dose protocol computed tomography (120 kilovolt, 150 milliampere seconds)




Primary Outcome Measures :
  1. Diagnostic accuracy [ Time Frame: From the date of randomization until the date of first documented final diagnosis, assessed up to 24 months ]
    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.


Secondary Outcome Measures :
  1. Complication [ Time Frame: From the date of randomization until the date of first documented biopsy-related complication, assessed up to 1 day. ]
    Biopsy-related complications mainly include pneumothorax and hemoptysis. Complications is evaluated by computed tomography scan and clinical symptoms.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-diagnostic lung lesions; Solid lung lesions; Lesion size ≥ 5mm.

Exclusion Criteria:

  • The lesion which has been punctured previously; Severe dysfunction in heart, lung and coagulation function.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02971176


Locations
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China, Jiangsu
Xuzhou Central Hospital
Xuzhou, Jiangsu, China, 221009
Sponsors and Collaborators
Xuzhou Central Hospital
Investigators
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Principal Investigator: Zi-Qi Tao, MD Science and Education Division of Xuzhou Central Hospital
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Xuzhou Central Hospital
ClinicalTrials.gov Identifier: NCT02971176    
Other Study ID Numbers: 20161115-010
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make individual participant data available.
Additional relevant MeSH terms:
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Adenocarcinoma of Lung
Plasma Cell Granuloma, Pulmonary
Granuloma, Plasma Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Granuloma
Pathologic Processes