NCT03305978

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

Detection of Pulmonary Nodules: Comparison of Ultra-low-dose Chest CT (Approaching a Two Views Chest X-ray Radiation) and Standard Low Dose CT. A Monocentric, Prospective, Non-randomized, Comparative, Open-label Study With Blind Reading of the Judgment Criteria.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer
• Smoking
• Radiation Exposure

Interventions

Type	Name	Description
DEVICE	Ultra low dose chest CT	An additional ultra low dose CT row is performed for every subject besides standard diagnostic low dose chest CT.
DEVICE	Low dose chest CT	standard diagnostic low dose chest CT

Timeline

• Start date: 2017-09-26
• Primary completion: 2019-07-10
• Completion: 2019-07-10
• First posted: 2017-10-10
• Last updated: 2019-08-21

Locations

1 site across 1 country: France