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

This study has been terminated.
Sponsor:
Collaborator:
American College of Radiology - Image Metrix
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01431378
First received: September 7, 2011
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • Evidence for reduced x-ray radiation exposure for applicable patient indications [ Time Frame: Side by side comparison once both scans have been performed ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 92
Study Start Date: September 2011
Estimated Study Completion Date: September 2014
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
CNS
CNS: Known or suspected pathology in the posterior fossa
Thorax
Thorax: Patients referred for staging of a known or suspected lung cancer
Abdomen 1
Abdomen: Patients with acute flank pain and suspected urolithiasis
Abdomen 2
Abdomen: Patients with a known or suspected focal liver lesion

Detailed Description:

See brief summary

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Population to include women or men 30 years of age or older referred for a CT scan

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01431378

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114-2696
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Wisconsin
Froedtert Memorial Lutheran Hospital
Miwaukee, Wisconsin, United States, 53226-3596
Sponsors and Collaborators
GE Healthcare
American College of Radiology - Image Metrix
  More Information

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01431378     History of Changes
Other Study ID Numbers: 106-2010-GES-0010
Study First Received: September 7, 2011
Last Updated: August 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by GE Healthcare:
CT scan
CNS
Thorax
Abdomen
staging of a known or suspected lung cancer
suspected urolithiasis
known or suspected focal liver lesion

Additional relevant MeSH terms:
Lung Neoplasms
Hemorrhage
Urolithiasis
Flank Pain
Intracranial Hemorrhages
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Urologic Diseases
Pain
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014