Ultralow-dose CT for Lung Cancer Screening

A Feasibility Study of Pulmonary Nodule Detection by Ultralow-dose CT Withadaptive Statistical Iterative Reconstruction-V Technique

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Diagnostic test: ULDCT group

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.

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ULDCT group; underwent ultralow-dose chest CT(ULDCT)	Diagnostic test: ULDCT group; underwent ultralow-dose chest CT
No Intervention: LDCT group; underwent conventional chest CT(LDCT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
types of pulmonary nodules	Two docotrs read images and do this opperation	through study completion, an average of one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diameter of pulmonary nodules	Two docotrs read images and do this opperation	through study completion, an average of one month

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Chair: JIE QIAO, Chair

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): September 2, 2017
• Study Completion (Actual): December 14, 2018

Study Registration Dates

• First Submitted: June 28, 2021
• First Submitted That Met QC Criteria: July 4, 2021
• First Posted (Actual): July 9, 2021

Study Record Updates

• Last Update Posted (Actual): July 9, 2021
• Last Update Submitted That Met QC Criteria: July 4, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: M2017217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No