Image Quality: Ultra-Low Dose Scanner Versus Standard Dose Conventional Scanner for Thoraco-abdominopelvic Scans (UL2DLR)

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Lung Diseases; Imaging, Diagnostic; Bone Diseases; Pelvis Disease; Abdomen Disease

Treatments: Radiation: Ultra-Low-Dose thoraco-abdominopelvic scan

Study type: Interventional

Funder types: Other

Identifiers

NCT05840003

LOCAL/2022/JG-01

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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116 participants in 1 patient group

Patients undergoing Ultra-Low-Dose scan plus conventional standard dose thoraco-abdominopelvic scan

Experimental group

Description:

All adult patients (except pregnant women) presenting to the imaging department of the Institut de Cancérologie du Gard for a thoraco-abdominopelvic scan as part of an oncology follow-up will under a standard-dose can as well as an ultra-low-dose scan.

Treatment:

Radiation: Ultra-Low-Dose thoraco-abdominopelvic scan