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 (VEOLITH)
Primary Purpose
Model-based Iterative Reconstruction (MB-IR VEOTM)
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Model-based iterative reconstruction (MB-IR VEOTM) on CT Discovery 750HD (GE Healthcare, Milwaukee, WI)
Sponsored by
About this trial
This is an interventional diagnostic trial for Model-based Iterative Reconstruction (MB-IR VEOTM) focused on measuring Model-based iterative reconstruction MB-IR, VEOTM, Ultra low-dose, Abdominal CT, Dose reduction, Adaptative statistical iterative reconstruction ASIR, Acute renal colic
Eligibility Criteria
Inclusion Criteria:
- Informed and a written consent
- Acute flank pain needed abdominal CT exploration.
Exclusion Criteria:
- Juvenile patients
- Pregnant women
Sites / Locations
- CHU de Clermont-Ferrand
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VEO
Arm Description
Outcomes
Primary Outcome Measures
acute renal colic
Secondary Outcome Measures
Measure of dose-length product
Measurements of subjective image quality
Evaluation of visceral fat
Full Information
NCT ID
NCT02076737
First Posted
February 21, 2014
Last Updated
February 28, 2014
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT02076737
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
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Model-based Iterative Reconstruction (MB-IR VEOTM)
Keywords
Model-based iterative reconstruction MB-IR, VEOTM, Ultra low-dose, Abdominal CT, Dose reduction, Adaptative statistical iterative reconstruction ASIR, Acute renal colic
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VEO
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Model-based iterative reconstruction (MB-IR VEOTM) on CT Discovery 750HD (GE Healthcare, Milwaukee, WI)
Primary Outcome Measure Information:
Title
acute renal colic
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
Measure of dose-length product
Time Frame
at day 1
Title
Measurements of subjective image quality
Time Frame
at day 1
Title
Evaluation of visceral fat
Time Frame
at ady 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed and a written consent
Acute flank pain needed abdominal CT exploration.
Exclusion Criteria:
Juvenile patients
Pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis BOYER
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
12. IPD Sharing Statement
Learn more about this trial
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
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