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

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 :

  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

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:
  • Revolution CT (GE Healthcare) 442507CN0, equiped with ASIR V
Active Comparator: Low dose chest CT
standard diagnostic low dose chest CT
Other Names:
  • Revolution CT (GE Healthcare)

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.

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

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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