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Completed

NCT Number: NCT03305978

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

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).

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Key information

Conditions

Lung Cancer Behavior Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Radiation Exposure Respiratory Tract Diseases Respiratory Tract Neoplasms Smoking Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Grenoble

Grenoble, 38043, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultra low dose chest CT

Device

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

Low dose chest CT

Device

standard diagnostic low dose chest CT

Other names: Revolution CT (GE Healthcare)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study 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.

Acronym: npUBD

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 10, 2017
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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