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

Model-based Iterative Reconstruction (MB-IR VEOTM) Clinical Trial

— VEOLITH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02076737
• Other study ID #: CHU-0183
• Secondary ID: 2012-A01699-34
• Status: Completed
• Phase: N/A
• First received: February 21, 2014
• Last updated: February 28, 2014
• Start date: February 2013
• Est. completion date: January 2014

Study information

• Verified date: February 2014
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Informed and a written consent

• Acute flank pain needed abdominal CT exploration.

Exclusion Criteria:

• Juvenile patients

• Pregnant women

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Model-based Iterative Reconstruction (MB-IR VEOTM)
• Renal Colic

Intervention

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

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acute renal colic		at day 1	Yes
Secondary	Measure of dose-length product		at day 1	Yes
Secondary	Measurements of subjective image quality		at day 1	Yes
Secondary	Evaluation of visceral fat		at ady 1	Yes