The Imalife study aims to assess reference values of lung density, bronchial wall thickness, vascular calcification and lung nodules by quantitative low-dose CT. Secondarily, it aims to assess the relation of quantitative imaging biomarkers of the…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Respiratory and mediastinal neoplasms malignant and unspecified
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reference values of lung density, bronchial wall thickness, vascular
calcification and lung nodules as imaging biomarkers of the Big-3 in the
general population aged 45 years and older.
Secondary outcome
Relation of imaging biomarkes of the Big-3 with clinical and laboratory
biomarkers.
In the BioLife substudy, CT-nodule characteristics and CT-based emphysema
scores are correlated to biomarkers based on breath, nasal brush and blood.
Background summary
Lung cancer, chronic obstructive pulmonary disease (COPD) and cardiovascular
disease (CVD) are prevalent in the general population and are expected to cause
most deaths by 2050. For this so-called Big-3, early treatment has been shown
to delay or stop progression, and allow therapy at a treatable stage in many
patients. A new computed tomography (CT) scan technique can evaluate
quantitative imaging biomarkers of early stages of the Big-3 at ultra-low
radiation dose. Reference values for imaging biomarkers of early signs of the
Big-3 in the general population are lacking. This is the primary purpose of the
ImaLife study. This study provides an invaluable resource for the development
and validation of biomarker profiles in the context of personalized medicine.
Study objective
The Imalife study aims to assess reference values of lung density, bronchial
wall thickness, vascular calcification and lung nodules by quantitative
low-dose CT. Secondarily, it aims to assess the relation of quantitative
imaging biomarkers of the Big-3 with clinical and laboratory markers.
Study design
A prospective, single-centre, cross-sectional study. All participants will
undergo ultra-low-dose CT scanning.
For the BioLife substudy, individuals with small incidental lung nodules will
be asked if they want to participate in a substudy for which they would have to
undergo additional collection of blood, a nasal brush and sampling of exhaled
breath.
Study burden and risks
Ultra-low-dose CT scans of the heart and lungs will be performed. The total
study related radiation dose as calculated by the radiation expert will be
between 0.6 and 1.8 mSv, with an additional 0.1 to 1.3 mSv in a subgroup
undergoing expiratory CT. These dose ranges fit very well within the radiation
dose limits for population imaging as defined by the Gezondheidsraad. The
expected risk due to the radiation dose of the CT scan is negligible. There are
no adverse events expected during the collection of the CT scans.
In the BioLife substudy venous blood, a nasal brush and sampling of exhaled
breath are collected. There are no adverse events expected during the
collection of the biomaterials.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
Participants should be 45 years or older, and have completed a lung function test as part of the second Lifelines screening.
Exclusion criteria
-CT of lungs or heart in the previous year
-known pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL58592.042.16 |