Pilot Study of Model Based Iterative Reconstruction Using 64-Slice

Terminated

• Conditions: Lung Cancer; Urolithiasis; Focal Hepatic Necrosis; Posterior Fossa Hemorrhage; Flank Pain

• Registration Number: NCT01431378
• Lead Sponsor: GE Healthcare

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

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-07
• Study First Submitted QC: 2011-09-08
• Study First Posted: 2011-09-09
• Primary Completion: 2012-05
• Study Completion: 2015-08
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-10
• Last Update Posted: 2015-12-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Froedtert Memorial Lutheran Hospital; 🇺🇸 Miwaukee, Wisconsin, United States