- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01431378
Pilot Study of Model Based Iterative Reconstruction Using 64-Slice (MBIR)
December 10, 2015 updated by: GE Healthcare
Pilot Study of Model Based Iterative Reconstruction Using 64-Slice Multidetector-Row CT Datasets Obtained From the Central Nervous System, Thorax, and Abdomen
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.
Study Overview
Status
Terminated
Detailed Description
See brief summary
Study Type
Observational
Enrollment (Actual)
92
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02114-2696
- Massachusetts General Hospital
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Wisconsin
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Miwaukee, Wisconsin, United States, 53226-3596
- Froedtert Memorial Lutheran Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Population to include women or men 30 years of age or older referred for a CT scan
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
CNS
CNS: Known or suspected pathology in the posterior fossa
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Thorax
Thorax: Patients referred for staging of a known or suspected lung cancer
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Abdomen 1
Abdomen: Patients with acute flank pain and suspected urolithiasis
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Abdomen 2
Abdomen: Patients with a known or suspected focal liver lesion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evidence for reduced x-ray radiation exposure for applicable patient indications
Time Frame: 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.
|
Side by side comparison once both scans have been performed
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
September 7, 2011
First Submitted That Met QC Criteria
September 8, 2011
First Posted (Estimate)
September 9, 2011
Study Record Updates
Last Update Posted (Estimate)
December 11, 2015
Last Update Submitted That Met QC Criteria
December 10, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Urologic Diseases
- Pain
- Neurologic Manifestations
- Pathological Conditions, Anatomical
- Calculi
- Hemorrhage
- Necrosis
- Intracranial Hemorrhages
- Urinary Calculi
- Urolithiasis
- Flank Pain
Other Study ID Numbers
- 106-2010-GES-0010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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