Viewing Study NCT02076737



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Last Modification Date: 2024-10-26 @ 11:20 AM
Study NCT ID: NCT02076737
Status: COMPLETED
Last Update Posted: 2014-03-04
First Post: 2014-02-21

Brief Title: 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
Sponsor: University Hospital Clermont-Ferrand
Organization: University Hospital Clermont-Ferrand

Study Overview

Official Title: 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
Status: COMPLETED
Status Verified Date: 2014-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: VEOLITH
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 MDCTMultiDetector 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 101 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 MBIRModel 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
2012-A01699-34 None None None