Clinical trial NCT05840003: Image Quality: Ultra-Low Dose Scanner Versus Standard Dose Conventional Scanner for Thoraco-abdominopelvic Scans
Official title: Concordance of Image Quality Between an Ultra-Low Dose (ULD) Scanner and Standard Dose Conventional Scanner for Thoraco-abdominopelvic Scans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Imaging, Diagnostic
Lung Diseases
Abdomen Disease
Pelvis Disease
Bone Diseases
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Monocentric study of the subject as his/her own control
Primary purpose: DIAGNOSTIC

Brief summary: The new image reconstruction algorithm (Precise Image, Philips Healthcare) has a strong potential to maintain sufficient image quality suitable for diagnosis with ultra-low dose (ULD) chest and abdomen-pelvis scans.

The hypothesis is that the images obtained with the Precise Image algorithm for ULD acquisitions are of sufficient and suitable quality for the diagnosis of certain lung, abdominal-pelvic and bone lesions.

Detailed description: Recently a new image reconstruction algorithm based on Deep-learning has been developed (Precise Image, Philips Healthcare). Initial studies on phantoms have shown that this algorithm improves image quality and reduces patient dose compared to the iDose4 iterative reconstruction algorithm. Feasibility studies have validated the image quality for low-dose levels (LD). However, this algorithm has a strong potential to maintain sufficient image quality suitable for diagnosis with ultra-low dose (ULD) chest and abdomen-pelvis scans.

The hypothesis is that the images obtained with the Precise Image algorithm for ULD acquisitions are of sufficient and suitable quality for the diagnosis of certain lung, abdominal-pelvic and bone lesions.

The purpose of this study is to evaluate the concordance of the global quality of thoraco-abdominopelvic images of a ULD scan acquisition compared to a standard dose CT acquisition and measure the global agreement of the global quality of the images with a 4-point Likert scale.

The ULD acquisition will allow a significant reduction in the X-ray dose delivered to patients compared to a standard dose conventional scanner. This reduction is estimated at 70%.

Eligibility criteria: Inclusion Criteria:

* Patient having given free and informed consent.
* Patient who has signed the consent form.
* Patient affiliated to or beneficiary of a health insurance plan.
* Patient with a BMI \< 35 kg/m2

Exclusion Criteria:

* Patient participating in research involving human subjects defined as Category 1.
* Patient in an exclusion period as determined by another study.
* Patient under court protection, guardianship or trusteeship.
* Patient unable to give consent.
* Patient for whom it is impossible to give informed information.
* Pregnant patient.
* Patient with a BMI ≥ 35 kg/m2

Primary outcomes:
measure: Concordance of the global quality of thoraco-abdomino-pelvic images from an Ultra-Low-Dose scanner acquisition compared to a standard dose scanner acquisition
timeFrame: Day 0
Secondary outcomes:
measure: Distribution of image quality with the standard dose scanner
timeFrame: Day 0
measure: Frequency of good quality images with the standard dose scanner
timeFrame: Day 0
measure: Distribution of image quality with the Ultra-Low-Dose scanner
timeFrame: Day 0
measure: Frequency of good quality images with the Ultra-Low-Dose scanner
timeFrame: Day 0
measure: Confidence level of each radiologist's diagnosis : Ultra-Low-Dose scan acquisition
timeFrame: Day 0
measure: Confidence level of each radiologist's diagnosis : Standard-Dose scan acquisition
timeFrame: Day 0
measure: Inter-rater agreement (Senior vs. junior radiologist) regarding the Ultra-Low-Dose scan acquisitions
timeFrame: Day 0
measure: Inter-rater agreement (Senior vs. junior radiologist) regarding the Standard-Dose scan acquisitions
timeFrame: Day 0
measure: Overall concordance of the diagnosis. Thoracic lesions seen on the Ultra-Low-Dose scan
timeFrame: Day 0
measure: Overall concordance of the diagnosis. Thoracic lesions seen on the Standard-Dose scan
timeFrame: Day 0
measure: Overall concordance of the diagnosis. Abdominal lesions seen on the Ultra-Low-Dose scan
timeFrame: Day 0
measure: Overall concordance of the diagnosis. Abdominal lesions seen on the Standard-Dose scan
timeFrame: Day 0
measure: Overall concordance of the diagnosis. Pelvic lesions seen on the Ultra-Low-Dose scan
timeFrame: Day 0
measure: Overall concordance of the diagnosis. Pelvic lesions seen on the Standard-Dose scan
timeFrame: Day 0
measure: Overall concordance of the diagnosis. Spine lesions seen on the Ultra-Low-Dose scan
timeFrame: Day 0
measure: Overall concordance of the diagnosis. Spine lesions seen on the Standard-Dose scan
timeFrame: Day 0
measure: Overall concordance of the diagnosis. Pelvic bone lesions seen on the Ultra-Low-Dose scan
timeFrame: Day 0
measure: Overall concordance of the diagnosis. Pelvic bone lesions seen on the Standard-Dose scan
timeFrame: Day 0
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU
Study officials:
affiliation: Nîmes University Hospital
name: Julien FRANDON, Prof.
role: PRINCIPAL_INVESTIGATOR
References: