Pilot Study of Model Based Iterative Reconstruction Using 64-Slice

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01431378

Acronym

MBIR

Enrollment

Registered

2011-09-09

Start date

2011-09-30

Completion date

2015-08-31

Last updated

2015-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

CT scan, CNS, Thorax, Abdomen, staging of a known or suspected lung cancer, suspected urolithiasis, known or suspected focal liver lesion

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

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Evidence for reduced x-ray radiation exposure for applicable patient indications	Side by side comparison once both scans have been performed	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.

Countries

United States

Outcome results