Ultralow-dose CT for Lung Cancer Screening
Primary Purpose
Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ULDCT group
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- age > 18 years and BMI ≤ 30 kg/m2
- fewer than four pulmonary nodules without calcification
- solid nodules (SNs) with a diameter of 4~15 mm and subsolid nodules (SSNs) with a diameter of 5~20 mm and containing part-solid nodules (PSNs) and ground-glass nodules (GGNs) (the diameter is the mean of the longest diameter and perpendicular diameter of a nodule)
- acceptable diagnostic image quality of LDCT.
Exclusion Criteria:
- None
Sites / Locations
- Peking University Third Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ULDCT group
LDCT group
Arm Description
underwent ultralow-dose chest CT(ULDCT)
underwent conventional chest CT(LDCT)
Outcomes
Primary Outcome Measures
types of pulmonary nodules
Two docotrs read images and do this opperation
Secondary Outcome Measures
diameter of pulmonary nodules
Two docotrs read images and do this opperation
Full Information
NCT ID
NCT04957030
First Posted
June 28, 2021
Last Updated
July 4, 2021
Sponsor
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04957030
Brief Title
Ultralow-dose CT for Lung Cancer Screening
Official Title
A Feasibility Study of Pulmonary Nodule Detection by Ultralow-dose CT Withadaptive Statistical Iterative Reconstruction-V Technique
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
September 2, 2017 (Actual)
Study Completion Date
December 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Therefore, the purpose of this study was to investigate whether ULDCT with ASiR-V can be used for the detection and diameter measurement of pulmonary nodules at an extremely low dose comparable to those associated with plain-film chest radiography. Furthermore, mixed-effects logistic regression analysis was used to determine independent predictors for the sensitivity of pulmonary nodule detection to explore the application range of ULDCT in Chinese patients.
Detailed Description
Lung cancer is the most common cancer in the world and characterized by the highest mortality rate. In 2016, 224000 new cases of lung cancer were reported in the United States, 60% of which were in the advanced stage. Compared to the overall 5-year survival rate of 18% for lung cancer, the 5-year survival rate for non-small cell lung cancer can be obviously improved to 80% with appropriate treatment in the early stage. Therefore, we believe lung cancer screening in the early stage to be significant. The National Lung Screening Trial in the United States has shown a relative risk reduction in death from lung cancer by 20% with low-dose computed tomography (LDCT) screening compared to that associated with plain-film chest radiography. The maximum radiation dose of LDCT recommended by guidelines is 3 mSv for small people(BMI≤30 kg/m2), which is far higher than that recommended for plain-film chest radiography, 0.03 to 0.1 mSv. In addition, a large number of indeterminate nodules need to be examined by follow-up evaluations with repeated LDCT to monitor for changes in diameter, which could result in an increase in the cumulative radiation dose that cannot be ignored. Hence, lung cancer screening with ultralow-dose CT (ULDCT) has attracted great attention from radiologists. In recent times, several strategies have been proposed to reduce the dose of ionizing radiation, including modification of tube potential and tube current and use of iterative reconstruction (IR). Reducing tube potential and tube current alone impairs image quality and lowers accuracies for radiologists. However, IR can obviously improve the image quality and reduce the noise at the same radiation exposure level, allowing for further reduction of the radiation dose.Recently, a new IR technique adaptive statistical iterative reconstruction-V (ASiR-V, GE Healthcare, USA) was developed. ASiR-V can increase noise reduction performance over the original IR technique even at lower doses and it has been widely applied in phantom and clinical studies. To the best of our knowledge, no data are available on ULDCT with ASiR-V for research on pulmonary nodules. Therefore, the purpose of this study was to investigate whether ULDCT with ASiR-V can be used for the detection and diameter measurement of pulmonary nodules at an extremely low dose comparable to those associated with plain-film chest radiography. Furthermore, mixed-effects logistic regression analysis was used to determine independent predictors for the sensitivity of pulmonary nodule detection to explore the application range of ULDCT in Chinese patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
188 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ULDCT group
Arm Type
Experimental
Arm Description
underwent ultralow-dose chest CT(ULDCT)
Arm Title
LDCT group
Arm Type
No Intervention
Arm Description
underwent conventional chest CT(LDCT)
Intervention Type
Diagnostic Test
Intervention Name(s)
ULDCT group
Intervention Description
underwent ultralow-dose chest CT
Primary Outcome Measure Information:
Title
types of pulmonary nodules
Description
Two docotrs read images and do this opperation
Time Frame
through study completion, an average of one month
Secondary Outcome Measure Information:
Title
diameter of pulmonary nodules
Description
Two docotrs read images and do this opperation
Time Frame
through study completion, an average of one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age > 18 years and BMI ≤ 30 kg/m2
fewer than four pulmonary nodules without calcification
solid nodules (SNs) with a diameter of 4~15 mm and subsolid nodules (SSNs) with a diameter of 5~20 mm and containing part-solid nodules (PSNs) and ground-glass nodules (GGNs) (the diameter is the mean of the longest diameter and perpendicular diameter of a nodule)
acceptable diagnostic image quality of LDCT.
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JIE QIAO
Organizational Affiliation
CHAIR
Official's Role
Study Chair
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Ultralow-dose CT for Lung Cancer Screening
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