Status:

TERMINATED

Pilot Study of Model Based Iterative Reconstruction Using 64-Slice

Lead Sponsor:

GE Healthcare

Collaborating Sponsors:

American College of Radiology - Image Metrix

Conditions:

Posterior Fossa Hemorrhage

Lung Cancer

Eligibility:

All Genders

30+ years

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 c...

Detailed Description

See brief summary

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 1 2011

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

August 1 2015

Estimated Enrollment :

92 Patients enrolled

Trial Details

Trial ID

NCT01431378

Start Date

September 1 2011

End Date

August 1 2015

Last Update

December 11 2015

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114-2696

2

Duke University Medical Center

Durham, North Carolina, United States, 27710

3

Froedtert Memorial Lutheran Hospital

Miwaukee, Wisconsin, United States, 53226-3596