- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03305978
Pulmonary Nodule Detection: Comparison of an Ultra Low Dose vs Standard Scan. (npUBD)
August 20, 2019 updated by: University Hospital, Grenoble
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.
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Grenoble, France, 38043
- University Hospital Grenoble
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria :
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)
- Affiliated with the french social security
- Who signed consent
Exclusion criteria :
- Inability to lie down and still during the examination
- Inability to hold breath more than 5 seconds
- Pneumonia in the last 3 months
- Body mass index more than 35kg/m²
- exclusion period of another interventionnal study
- referred for articles L1121-5 to L1121-8 of french public health code
- Pregnant or breastfeeding women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ultra low dose chest CT
|
An additional ultra low dose CT row is performed for every subject besides standard diagnostic low dose chest CT.
Other Names:
|
Active Comparator: Low dose chest CT
|
standard diagnostic low dose chest CT
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ultra low dose CT lung nodule detection sensibility
Time Frame: 22 months
|
Detection rate (%) of ≥4mm lung nodules in ultra low dose chest CT versus standard low dose chest CT
|
22 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ultra low dose CT diagnostic performances of lung nodule detection
Time Frame: 22 months
|
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
|
Concordance of ≥4mm lung nodules characteristics between ultra low dose and standard low dose chest CT
Time Frame: 22 months
|
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
Time Frame: 22 months
|
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
Time Frame: 22 months
|
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
Time Frame: 22 months
|
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
Time Frame: 22 months
|
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
Time Frame: 22 months
|
comparison of detection of bronchial thickening or dilatation between ultra low dose and standard low dose chest CT
|
22 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gilbert Ferretti, MD, PhD, University Hospital, Grenoble
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 26, 2017
Primary Completion (Actual)
July 10, 2019
Study Completion (Actual)
July 10, 2019
Study Registration Dates
First Submitted
September 26, 2017
First Submitted That Met QC Criteria
October 9, 2017
First Posted (Actual)
October 10, 2017
Study Record Updates
Last Update Posted (Actual)
August 21, 2019
Last Update Submitted That Met QC Criteria
August 20, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38RC17.132
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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