Pulmonary Nodule Detection: Comparison of an Ultra Low Dose vs Standard Scan.

Not Applicable

Completed

• Conditions: Lung Cancer; Smoking; Radiation Exposure
• Interventions: Device: Low dose chest CT; Device: Ultra low dose chest CT

• Registration Number: NCT03305978
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

Lung cancer screening programs are still discussed in Europe today, and one of the concern is radiation due to iterative CT. The aim of this monocentric, prospective, non randomized study is to compare an ultra low dose chest CT (approaching a two views X ray) versus a standard low dose chest CT for ≥4mm lung nodules detection, and secondary for lung nodule characterization and smoking associated findings (emphysema, bronchial abnormalities and coronary calcifications).

Detailed Description

An additional Ultra Low Dose CT, approaching 0.2mSv, will be performed in consenting patients referred for non enhanced chest CT in our Revolution CT scanner (GE Healthcare®).The dose delivered with the two acquisitions is still lower than the french diagnostic reference level. Standard CT is interpreted and a report is sent to the referent physician as usual. Then the two acquisitions are read over time by two independent radiologists, blinded over judgment criterias. In case of discordance, an other radiologist will arbitrate. We hope to validate our Ultra low dose chest CT protocol, which is more than 10 times less radiating than a standard low dose CT, as a sensitive tool to detect lung nodules.

Study Timeline

• Study Start: 2017-09-26
• Study First Submitted: 2017-09-26
• Study First Submitted QC: 2017-10-09
• Study First Posted: 2017-10-10
• Primary Completion: 2019-07-10
• Study Completion: 2019-07-10
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-20
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Low dose chest CT	Low dose chest CT	-
Ultra low dose chest CT	Ultra low dose chest CT	-

Primary Outcome Measures

Name	Time	Method
Ultra low dose CT lung nodule detection sensibility	22 months	Detection rate (%) of ≥4mm lung nodules in ultra low dose chest CT versus standard low dose chest CT

Secondary Outcome Measures

Name	Time	Method
Concordance of bronchial abnormalities evaluation between ultra low dose and standard low dose chest CT	22 months	comparison of detection of bronchial thickening or dilatation between ultra low dose and standard low dose chest CT
Ultra low dose CT diagnostic performances of lung nodule detection	22 months	true positives, false positives, true negatives, false negatives, positive predictive value, negative predictive value, specificity, of ≥4mm lung nodules detection within ultra low dose chest CT versus standard low dose chest CT
Ultra low dose CT inter-observer reproducibility	22 months	inter observer reproducibility for size, density and type of ≥4mm lung nodule detected in ultra low dose CT
Influence of subjects characteristics, nodule location, and nodule size on detection between ultra low dose and standard low dose chest CT	22 months	analysis of subjects characteristics (age, gender, body mass index), ≥4mm nodule location, and ≥4 mm nodule size on detection between ultra low dose and standard low dose chest CT
Concordance of emphysema characteristics between ultra low dose and standard low dose chest CT	22 months	comparison of emphysema detection, type (centrilobular, paraseptal, panlobular, bullous) and distribution between ultra low dose and standard low dose chest CT
Concordance of ≥4mm lung nodules characteristics between ultra low dose and standard low dose chest CT	22 months	comparison of size, density, type (true nodule or intrapulmonary ganglion) of ≥4mm lung nodule between ultra low dose and standard low dose chest CT
Concordance of coronary calcification detection and quantification between ultra low dose and standard low dose chest CT	22 months	Comparison of Weston scores between ultra low dose and standard low dose chest CT

Trial Locations

Locations (1)

University Hospital Grenoble; 🇫🇷 Grenoble, France