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

NCT05840003 | Completed

• 1 other identifier: LOCAL/2022/JG-01
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Concordance of the global quality of thoraco-abdomino-pelvic images from an Ultra-Low-Dose scanner acquisition compared to a standard dose scanner acquisition

  A 4-point Likert scale will be used to evaluate the overall image quality to see whether it is good enough to visualize the structures of interest and possible lesions. Overall image quality is rated as follows: 1. Completely interpretable without noise, smoothing, and/or artifact, 2. Completely interpretable with low artifacts and/or low level of noise or/and smoothing, 3. Interpretable with moderate noise and/or smoothing and moderate artifacts, 4. Uninterpretable

  Day 0

Secondary Outcomes (18)

• Distribution of image quality with the standard dose scanner

  Day 0

• Frequency of good quality images with the standard dose scanner

  Day 0

• Distribution of image quality with the Ultra-Low-Dose scanner

  Day 0

• Frequency of good quality images with the Ultra-Low-Dose scanner

  Day 0

• Confidence level of each radiologist's diagnosis : Ultra-Low-Dose scan acquisition

  Day 0

Study Arms (1)

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

EXPERIMENTAL

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.

Radiation: Ultra-Low-Dose thoraco-abdominopelvic scan

Interventions

Ultra-Low-Dose thoraco-abdominopelvic scan RADIATION

In addition to the usual management (i.e. standard dose Computed Tomography), an Ultra-Low-Dose thoraco-abdominopelvic scan will be routinely performed.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient participating in research involving human subjects defined as Category 1.
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Disease; Lung Diseases; Bone Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Diseases; Musculoskeletal Diseases

Study Officials

• Julien FRANDON, Prof.

  Nîmes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The reading of the images from the ULD scanner acquisition will be performed blinded to the patient's clinical record, the diagnosis made by the radiologist in charge of the patient on the basis of the standard dose conventional scanner, the result of the reading of the standard dose conventional scanner study and the reading of the other evaluator.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric study of the subject as his/her own control

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 3, 2023
• Study Start: September 15, 2023
• Primary Completion: July 15, 2024
• Study Completion: September 15, 2024
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)