Pilot Study of Model Based Iterative Reconstruction Using 64-Slice

Study Overview
=================
Brief Summary
-----------------
This study is being performed to confirm that the new technique, Model-Based Iterative Reconstruction (MBIR) with reduced radiation dose can deliver equivalent image quality for CT scans compared to current techniques (Filtered Back Projection with Adaptive Statistical Iterative Reconstruction (FBP with ASiR) and also to demonstrate that MBIR can improve general image quality characteristics at equivalent radiation dose levels.

Detailed Description
-----------------
See brief summary

Official Title
-----------------
Pilot Study of Model Based Iterative Reconstruction Using 64-Slice Multidetector-Row CT Datasets Obtained From the Central Nervous System, Thorax, and Abdomen

Conditions
-----------------
Lung Cancer, Posterior Fossa Hemorrhage, Flank Pain, Urolithiasis, Focal Hepatic Necrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or Women 30 years of age or older voluntarily willing to sign an informed consent. Patients indicated for one of the following: CNS: Known or suspected pathology in the posterior fossa Thorax: Patients referred for staging of a known or suspected lung cancer Abdomen: Patients with acute flank pain and suspected urolithiasis or Abdomen: Patients with a known or suspected focal liver lesion Exclusion Criteria: Subjects less than 30 years of age Pregnant women as confirmed by urine test or current accepted institution standard If IV contrast is required: Severe or uncontrolled allergy to iodinated contrast media Serum creatinine > 1.7 mg/dl or estimated glomerular filtration rate [eGFR] of <60 mg/min as recorded in medical file or by current accepted institution standard Unable or unwilling to provide written informed consent by self or legal guardian at the time of study enrollment Unstable physical condition as identified by physician

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CNS<br>CNS: Known or suspected pathology in the posterior fossa | |
| Thorax<br>Thorax: Patients referred for staging of a known or suspected lung cancer | |
| Abdomen 1<br>Abdomen: Patients with acute flank pain and suspected urolithiasis | |
| Abdomen 2<br>Abdomen: Patients with a known or suspected focal liver lesion | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence for reduced x-ray radiation exposure for applicable patient indications | Ultra-low radiation dose images reconstructed with MBIR yield similar anatomic and pathologic information compared to routine radiation dose images reconstructed with Filtered Back Projection (FBP) in the central nervous system (CNS), thorax, and abdomen. | Side by side comparison once both scans have been performed | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CT scan, CNS, Thorax, Abdomen, staging of a known or suspected lung cancer, suspected urolithiasis, known or suspected focal liver lesion