NCT03305978

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

September 26, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 10, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2019

Completed
Last Updated

August 21, 2019

Status Verified

August 1, 2019

Enrollment Period

1.8 years

First QC Date

September 26, 2017

Last Update Submit

August 20, 2019

Conditions

Lung CancerSmokingRadiation Exposure

Keywords

Ultra low dose chest CTlung cancer screening

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Ultra low dose CT diagnostic performances of lung nodule detection

    22 months

  • Concordance of ≥4mm lung nodules characteristics between ultra low dose and standard low dose chest CT

    22 months

  • Ultra low dose CT inter-observer reproducibility

    22 months

  • Influence of subjects characteristics, nodule location, and 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

    22 months

  • +2 more secondary outcomes

Study Arms (2)

Ultra low dose chest CT

EXPERIMENTAL
Device: Ultra low dose chest CT

Low dose chest CT

ACTIVE COMPARATOR
Device: Low dose chest CT

Interventions

Ultra low dose chest CTDEVICE

An additional ultra low dose CT row is performed for every subject besides standard diagnostic low dose chest CT.

Also known as: Revolution CT (GE Healthcare) 442507CN0, equiped with ASIR V
Ultra low dose chest CT
Low dose chest CTDEVICE

standard diagnostic low dose chest CT

Also known as: Revolution CT (GE Healthcare)
Low dose chest CT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • referred for articles L1121-5 to L1121-8 of french public health code
  • Pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Grenoble

Grenoble, 38043, France

Location

Related Publications (1)

  • 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.

    PMID: 31420379DERIVED

MeSH Terms

Conditions

Lung NeoplasmsSmoking

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBehavior

Study Officials

  • Gilbert Ferretti, MD, PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
blinding evaluation of criteria
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Model Details: Major Patient Addressed for Thoracic CT without Injection of Contrast
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2017

First Posted

October 10, 2017

Study Start

September 26, 2017

Primary Completion

July 10, 2019

Study Completion

July 10, 2019

Last Updated

August 21, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)