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Pilot Study of Model Based Iterative Reconstruction Using 64-Slice

NCT ID: NCT01431378

Last Updated: 2015-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

92 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-08-31

Brief Summary

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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

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See brief summary

Conditions

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Posterior Fossa Hemorrhage Lung Cancer Flank Pain Urolithiasis Focal Hepatic Necrosis

Keywords

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CT scan CNS Thorax Abdomen staging of a known or suspected lung cancer suspected urolithiasis known or suspected focal liver lesion

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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CNS

CNS: Known or suspected pathology in the posterior fossa

No interventions assigned to this group

Thorax

Thorax: Patients referred for staging of a known or suspected lung cancer

No interventions assigned to this group

Abdomen 1

Abdomen: Patients with acute flank pain and suspected urolithiasis

No interventions assigned to this group

Abdomen 2

Abdomen: Patients with a known or suspected focal liver lesion

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American College of Radiology - Image Metrix

INDUSTRY

Sponsor Role collaborator

GE Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Froedtert Memorial Lutheran Hospital

Miwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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106-2010-GES-0010

Identifier Type: -

Identifier Source: org_study_id