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

Primary Purpose

Lung Cancer, Smoking, Radiation Exposure

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ultra low dose chest CT
Low dose chest CT
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring Ultra low dose chest CT, lung cancer screening

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Grenoble

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ultra low dose chest CT

Low dose chest CT

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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
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
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

Full Information

First Posted
September 26, 2017
Last Updated
August 20, 2019
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT03305978
Brief Title
Pulmonary Nodule Detection: Comparison of an Ultra Low Dose vs Standard Scan.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 26, 2017 (Actual)
Primary Completion Date
July 10, 2019 (Actual)
Study Completion Date
July 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Smoking, Radiation Exposure
Keywords
Ultra low dose chest CT, lung cancer screening

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Major Patient Addressed for Thoracic CT without Injection of Contrast
Masking
Outcomes Assessor
Masking Description
blinding evaluation of criteria
Allocation
Non-Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultra low dose chest CT
Arm Type
Experimental
Arm Title
Low dose chest CT
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Ultra low dose chest CT
Other Intervention Name(s)
Revolution CT (GE Healthcare) 442507CN0, equiped with ASIR V
Intervention Description
An additional ultra low dose CT row is performed for every subject besides standard diagnostic low dose chest CT.
Intervention Type
Device
Intervention Name(s)
Low dose chest CT
Other Intervention Name(s)
Revolution CT (GE Healthcare)
Intervention Description
standard diagnostic low dose chest CT
Primary Outcome Measure Information:
Title
Ultra low dose CT lung nodule detection sensibility
Description
Detection rate (%) of ≥4mm lung nodules in ultra low dose chest CT versus standard low dose chest CT
Time Frame
22 months
Secondary Outcome Measure Information:
Title
Ultra low dose CT diagnostic performances of lung nodule detection
Description
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
Time Frame
22 months
Title
Concordance of ≥4mm lung nodules characteristics between ultra low dose and standard low dose chest CT
Description
comparison of size, density, type (true nodule or intrapulmonary ganglion) of ≥4mm lung nodule between ultra low dose and standard low dose chest CT
Time Frame
22 months
Title
Ultra low dose CT inter-observer reproducibility
Description
inter observer reproducibility for size, density and type of ≥4mm lung nodule detected in ultra low dose CT
Time Frame
22 months
Title
Influence of subjects characteristics, nodule location, and nodule size on detection between ultra low dose and standard low dose chest CT
Description
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
Time Frame
22 months
Title
Concordance of emphysema characteristics between ultra low dose and standard low dose chest CT
Description
comparison of emphysema detection, type (centrilobular, paraseptal, panlobular, bullous) and distribution between ultra low dose and standard low dose chest CT
Time Frame
22 months
Title
Concordance of coronary calcification detection and quantification between ultra low dose and standard low dose chest CT
Description
Comparison of Weston scores between ultra low dose and standard low dose chest CT
Time Frame
22 months
Title
Concordance of bronchial abnormalities evaluation between ultra low dose and standard low dose chest CT
Description
comparison of detection of bronchial thickening or dilatation between ultra low dose and standard low dose chest CT
Time Frame
22 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilbert Ferretti, MD, PhD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31420379
Citation
Ludwig 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.
Results Reference
derived

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

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