Pilot Study of Model Based Iterative Reconstruction Using 64-Slice (MBIR)
This study is currently recruiting participants.
Verified January 2012 by GE Healthcare
Sponsor:
GE Healthcare
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: November 7, 2012
Last verified: January 2012
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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:
| Estimated Enrollment: | 120 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | November 2012 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431378
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114-2696 | |
| Contact: Gaurav Desai gsdesai@partners.org | |
| Principal Investigator: Dushyant Sahani, MD | |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Brenda Prince brenda.prince@duke.edu | |
| Principal Investigator: Erik Paulson, MD | |
| United States, Wisconsin | |
| Froedtert Memorial Lutheran Hospital | Recruiting |
| Miwaukee, Wisconsin, United States, 53226-3596 | |
| Contact: Michele Leininger mleining@mcw.edu | |
| Principal Investigator: William Foley, MD | |
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: | November 7, 2012 |
| 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:
|
Flank Pain Hemorrhage Lung Neoplasms Necrosis Urolithiasis Intracranial Hemorrhages Pain Signs and Symptoms Pathologic Processes Respiratory Tract Neoplasms Thoracic Neoplasms |
Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Urologic Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013