Model-based Iterative Reconstruction (MB-IR VEOTM) in Ultra Low-dose Abdominal CT Versus Adaptative Statistical Iterative Reconstruction (ASIR): A Prospective Study for Acute Renal Colic

Not Applicable

Completed

• Conditions: Model-based Iterative Reconstruction (MB-IR VEOTM)
• Interventions: Device: Model-based iterative reconstruction (MB-IR VEOTM) on CT Discovery 750HD (GE Healthcare, Milwaukee, WI)

• Registration Number: NCT02076737
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

The purpose of this study is to determine if Model-based iterative reconstruction (MB-IR VEOTM) in ultra low-dose abdominal CT as the same accuracy for the diagnosis of acute renal colic versus standard CT with adaptative statistical iterative reconstruction (ASIR).

Detailed Description

Renal colic is a common recurrent pathology in young patients, multi explored by imaging such as CT and abdominal radiography.

Abdominal MDCT(MultiDetector Computed Tomography) without injection is the gold standard in diagnosis of acute flank pain suspect of renal colic due to high sensitivity (96%) and excellent specificity (100%).

The increased use of medical imaging examinations using ionizing radiation (+57 % between 2002 and 2007) makes it essential to optimize protocols, including CT-scans which represents 10.1 % of procedures and 58 % of the collective effective dose.

Model-based iterative reconstruction (MB-IR VEOTM) (GE Healthcare, Milwaukee, WI) can use a low dose acquisition, reducing the effective dose delivered to the patient almost 80% comparing a standard CT with the last algorithm: adaptative statistical iterative reconstruction (ASIR).

MB-IR VEOTM shows great potential for substantially reducing radiation doses at routine abdominal CT. ASIR is limited in this regard owing to reduced image quality and diagnostic capability. Further investigation is needed to determine the optimal dose level for MBIR(Model Base Iterative Reconstruction) that maintains adequate diagnostic performance. In general, objective and subjective image quality measurements do not necessarily correlate with diagnostic performance at ultralow-dose CT.

Objective:

Prospective clinical study, equivalence between two CT protocols for the diagnosis of acute renal colic.

Show that a low dose acquisition with model based iterative reconstruction (MB-IR VeoTM) is as good as a standard CT with adaptative statistical iterative reconstruction (ASIR) in the diagnosis acute renal colic

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2013-11
• Study Completion: 2014-01
• Status Verified: 2014-02
• Study First Submitted: 2014-02-21
• Study First Submitted QC: 2014-02-28
• Last Update Submitted: 2014-02-28
• Study First Posted: 2014-03-04
• Last Update Posted: 2014-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Informed and a written consent
• Acute flank pain needed abdominal CT exploration.

Exclusion Criteria

• Juvenile patients
• Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VEO	Model-based iterative reconstruction (MB-IR VEOTM) on CT Discovery 750HD (GE Healthcare, Milwaukee, WI)	-

Primary Outcome Measures

Name	Time	Method
acute renal colic	at day 1

Secondary Outcome Measures

Name	Time	Method
Measure of dose-length product	at day 1
Measurements of subjective image quality	at day 1
Evaluation of visceral fat	at ady 1

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France