Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Radiation Exposure | — | UNRESOLVED | — |
| Smoking | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low dose chest CT | Device | — | UNRESOLVED |
| Ultra low dose chest CT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ultra low dose chest CT
- interventionNames
- Device: Ultra low dose chest CT
- type
- ACTIVE_COMPARATOR
- label
- Low dose chest CT
- interventionNames
- Device: Low dose chest CT
Primary outcomes (1)
- measure
- Ultra low dose CT lung nodule detection sensibility
- timeFrame
- 22 months
- description
- Detection rate (%) of ≥4mm lung nodules in ultra low dose chest CT versus standard low dose chest CT
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria : 1. Patients referred for non enhanced chest CT for following indications : * lung nodule search or control * nodular abnormality on chest X ray * statement of COPD or emphysema * asbestos exposure * nodule localization before radio frequency ablation * assessment of disease extent of an extra thoracic cancer (in case of iodinated intravenous contrast agent contraindication) * statement before extrathoracic transplantation (in case of iodinated intravenous contrast agent contraindication) 2. Affiliated with the french social security 3. Who signed consent Exclusion criteria : 1. Inability to lie down and still during the examination 2. Inability to hold breath more than 5 seconds 3. Pneumonia in the last 3 months 4. Body mass index more than 35kg/m² 5. exclusion period of another interventionnal study 6. referred for articles L1121-5 to L1121-8 of french public health code 7. Pregnant or breastfeeding women
References
Publications (1)
- DERIVEDLudwig 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. PMID 31420379