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Clinical Trial Summary

evaluate the diagnostic performance of ultra-low dose CT using deep learning-based reconstruction in the detection of pulmonary nodules.


Clinical Trial Description

- Background: Lung cancer is the leading cause of cancer deaths. Patients with pulmonary nodules often undergo multiple computed tomography (CT) examinations for diagnostic and follow-up purposes. - Purpose: The main objective of this study is to evaluate the diagnostic performance of ultra-low dose CT using deep learning-based reconstruction in the detection of pulmonary nodules. - Abstract: Despite recent advances, lung cancer remains the most commonly diagnosed cancer and the leading cause of cancer death worldwide because it is often diagnosed at advanced stages that are not surgically curable. Nevertheless, early detection of lung cancer allows surgical resection, offers curative treatment and the best chance of survival. There is currently no screening program in France, but individual screening can be carried out depending on risk factors. Many pulmonary nodules are discovered each year, most of which are benign. The challenge is to distinguish malignant lesions from the multitude of benign lesions. One of the most effective criteria is the doubling time of the nodules which leads to multiple follow-up examinations requiring ionizing radiation to assess the size and growth of the nodules. Great efforts are currently being made by CT manufacturers in order to reduce the radiation with equivalent diagnostic performance. Patients who were referred to our department for an unenhanced low-dose chest CT (LD CT) for pulmonary nodules check-up or follow-up, and had consented to participate in the study, will undergo an additional ultra-low dose acquisition (ULDCT, <0,25 mSv, similar to standard two-view chest X-Ray) with deep learning-based reconstruction (DLIR). The main objective of this study is to evaluate the diagnostic performance between ULD and LD CT protocols for the detection of pulmonary nodules. The impact of dose reduction will be assessed in this context. The data from each examination will be blindly interpreted from the results of the other one. No follow-up will be required for the study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04482114
Study type Interventional
Source Centre Hospitalier Universitaire, Amiens
Contact
Status Active, not recruiting
Phase N/A
Start date July 22, 2020
Completion date July 2023

See also
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Active, not recruiting NCT06075836 - AI Assisted Detection of Chest X-Rays
Recruiting NCT06187935 - Early Adjuvant Diagnosis of Pulmonary Nodules Based on CTC.