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

Lung Cancer Clinical Trial

— npUBD  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03305978
• Other study ID #: 38RC17.132
• Status: Completed
• Phase: N/A
• Start date: September 26, 2017
• Est. completion date: July 10, 2019

Study information

• Verified date: August 2019
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 10, 2019
• Est. primary completion date: July 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Multiple Pulmonary Nodules
• Radiation Exposure
• Smoking

Intervention

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.
• Low dose chest CT
standard diagnostic low dose chest CT

Locations

Country	Name	City	State
France	University Hospital Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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