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Pilot Study of Model Based Iterative Reconstruction Using 64-Slice (MBIR)

General Electric (GE) logo

General Electric (GE)

Status

Terminated

Conditions

Urolithiasis
Focal Hepatic Necrosis
Lung Cancer
Flank Pain
Posterior Fossa Hemorrhage

Study type

Observational

Funder types

Industry

Identifiers

NCT01431378
106-2010-GES-0010

Details and patient eligibility

About

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.

Full description

See brief summary

Enrollment

92 patients

Sex

All

Ages

30+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

92 participants in 4 patient groups

CNS
Description:
CNS: Known or suspected pathology in the posterior fossa
Thorax
Description:
Thorax: Patients referred for staging of a known or suspected lung cancer
Abdomen 1
Description:
Abdomen: Patients with acute flank pain and suspected urolithiasis
Abdomen 2
Description:
Abdomen: Patients with a known or suspected focal liver lesion

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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