1. To assess the clinical value of ULDCT as compared to CXR examinations for diagnosing pulmonary pathology.2. To identify patient groups or indications that may benefit by replacing CXR by ULDCT examination. 3. To analyze the effect of…
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Percentages of pulmonary pathology detected by ULDCT as compared to CXR.
Secondary outcome
- Number of patients which have an added clinical value of ULDCT by means of
(potential) changes in clinical decision as compared to CXR examination.
- Analyse the cost-effect when implementing ULDCT instead of CXR.
- To analyse the reconstruction algorithm influence on the clinical detection
probability in ULDCT: AIDR3D versus FIRST
Background summary
The quality of computed tomography (CT) imaging increases and each year more
scans are performed in hospitals. However, the radiation dose in CT is of
concern because of the potential health hazard of ionizing radiation. Chest-CT
uses relatively a high radiation dose (±6 mSv), and is of major importance for
the examination and evaluation of chest pathology. However, current
developments made it possible to reduce the radiation dose for the patient well
maintain the imaging quality by filtered back protection (FBP) and in
particular iterative reconstruction (IR) techniques. Several studies have shown
that low dose CT and ultra-low dose CT (ULDCT) of the chest is feasible for
detecting and characterizing a variety of pulmonary diseases with a radiation
dose below one mSv. Furthermore, detection of pulmonary diseases was also
feasible with a radiation dose nearly equivalent to chest X-ray (CXR)
examination. CXR is the first choice for detecting pulmonary pathology by
doctors, because of the high rate radiation dose of standard dose CT (SDCT).
However, CXR examination has important diagnostic limitation by being a
2-dimensional projection technique, while CT allows 3-dimensional volumetric
evaluation of the chest. For these reasons ULDCT may replace CXR investigation
in evaluating pathology with improved diagnostic quality.
Study objective
1. To assess the clinical value of ULDCT as compared to CXR examinations for
diagnosing pulmonary pathology.
2. To identify patient groups or indications that may benefit by replacing CXR
by ULDCT examination.
3. To analyze the effect of reconstruction algorithms on pulmonary pathology in
ULDCT: Adaptive Dose Reduction 3D (AIDR3D) versus Forward projected model-based
Iterative Reconstruction SoluTion (FIRST).
Study design
Prospective, observational, intention-to-treat study.
Study burden and risks
For patients referred for CXR, additional ULDCT examination time takes about 5
minutes.
The risks related to the additional ULDCT-examination consist of additional
radiation exposure (< 0.064 mSv), which is in the same range of a standard CXR
examination and factor 100 lower than a standard CT examination. The radiation
dose is therefore negligible with regard to doses acceptable for research
purposes with potential clinical gain. The advantages of possible diagnostic
outcome, for example better detection of nodules, of the study are expected to
exceed the risks of radiation-induced complications by far.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
* 50 years.
Referral for Chest x-ray.
Having given written informed consent prior to undertaking any study-related procedures.
Exclusion criteria
BMI * 30.
Patients who are not capable of to hold breath for at least 5 seconds.
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 | NL57546.058.16 |