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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultra low dose chest CT | Experimental |
| |
| Low dose chest CT | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultra low dose chest CT | Device | An additional ultra low dose CT row is performed for every subject besides standard diagnostic low dose chest CT. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ultra low dose CT lung nodule detection sensibility | Detection rate (%) of ≥4mm lung nodules in ultra low dose chest CT versus standard low dose chest CT | 22 months |
| Measure | Description | Time Frame |
|---|---|---|
| Ultra low dose CT diagnostic performances of lung nodule detection | 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 | 22 months |
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Inclusion criteria :
Patients referred for non enhanced chest CT for following indications :
Affiliated with the french social security
Who signed consent
Exclusion criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Gilbert Ferretti, MD, PhD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Grenoble | Grenoble | 38043 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31420379 | Derived | Ludwig M, Chipon E, Cohen J, Reymond E, Medici M, Cole A, Moreau Gaudry A, Ferretti G. Detection of pulmonary nodules: a clinical study protocol to compare ultra-low dose chest CT and standard low-dose CT using ASIR-V. BMJ Open. 2019 Aug 15;9(8):e025661. doi: 10.1136/bmjopen-2018-025661. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Major Patient Addressed for Thoracic CT without Injection of Contrast
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blinding evaluation of criteria
|
| Low dose chest CT | Device | standard diagnostic low dose chest CT |
|
|
| Concordance of ≥4mm lung nodules characteristics between ultra low dose and standard low dose chest CT |
comparison of size, density, type (true nodule or intrapulmonary ganglion) of ≥4mm lung nodule between ultra low dose and standard low dose chest CT |
| 22 months |
| Ultra low dose CT inter-observer reproducibility | inter observer reproducibility for size, density and type of ≥4mm lung nodule detected in ultra low dose CT | 22 months |
| Influence of subjects characteristics, nodule location, and nodule size on detection between ultra low dose and standard low dose chest CT | 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 | 22 months |
| Concordance of emphysema characteristics between ultra low dose and standard low dose chest CT | comparison of emphysema detection, type (centrilobular, paraseptal, panlobular, bullous) and distribution between ultra low dose and standard low dose chest CT | 22 months |
| Concordance of coronary calcification detection and quantification between ultra low dose and standard low dose chest CT | Comparison of Weston scores between ultra low dose and standard low dose chest CT | 22 months |
| Concordance of bronchial abnormalities evaluation between ultra low dose and standard low dose chest CT | comparison of detection of bronchial thickening or dilatation between ultra low dose and standard low dose chest CT | 22 months |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001519 | Behavior |