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Low-dose Protocol for Computed Tomography-guided Lung Biopsy

Primary Purpose

Lung Cancer, Adenocarcinoma, Lung Inflammatory Pseudotumor

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Low-dose protocol computed tomography
Standard-dose protocol computed tomography
Sponsored by
Xuzhou Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer, Adenocarcinoma

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xuzhou Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low-dose protocol

Standard-dose protocol

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Complication
Biopsy-related complications mainly include pneumothorax and hemoptysis. Complications is evaluated by computed tomography scan and clinical symptoms.

Full Information

First Posted
November 17, 2016
Last Updated
June 2, 2019
Sponsor
Xuzhou Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02971176
Brief Title
Low-dose Protocol for Computed Tomography-guided Lung Biopsy
Official Title
Low-dose Protocol for Computed Tomography-guided Lung Biopsy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
November 30, 2016 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xuzhou Central Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Adenocarcinoma, Lung Inflammatory Pseudotumor

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-dose protocol
Arm Type
Experimental
Arm Description
Patients undergo low-dose protocol computed tomography-guided lung biopsy on day 1.
Arm Title
Standard-dose protocol
Arm Type
Active Comparator
Arm Description
Patients undergo standard-dose protocol computed tomography-guided lung biopsy on day 1.
Intervention Type
Radiation
Intervention Name(s)
Low-dose protocol computed tomography
Intervention Description
Radiation dose under the low-dose protocol computed tomography (120 kilovolt, 15 milliampere seconds)
Intervention Type
Radiation
Intervention Name(s)
Standard-dose protocol computed tomography
Intervention Description
Radiation dose under the standard-dose protocol computed tomography (120 kilovolt, 150 milliampere seconds)
Primary Outcome Measure Information:
Title
Diagnostic accuracy
Description
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.
Time Frame
From the date of randomization until the date of first documented final diagnosis, assessed up to 24 months
Secondary Outcome Measure Information:
Title
Complication
Description
Biopsy-related complications mainly include pneumothorax and hemoptysis. Complications is evaluated by computed tomography scan and clinical symptoms.
Time Frame
From the date of randomization until the date of first documented biopsy-related complication, assessed up to 1 day.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zi-Qi Tao, MD
Organizational Affiliation
Science and Education Division of Xuzhou Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xuzhou Central Hospital
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221009
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make individual participant data available.
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Low-dose Protocol for Computed Tomography-guided Lung Biopsy

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