Pilot Study of Model Based Iterative Reconstruction Using 64-Slice

Lung Cancer Clinical Trial

— MBIR  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01431378
• Other study ID #: 106-2010-GES-0010
• Status: Terminated
• Phase: N/A
• First received: September 7, 2011
• Last updated: December 10, 2015
• Start date: September 2011
• Est. completion date: August 2015

Study information

• Verified date: December 2015
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

See brief summary

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 92
• Est. completion date: August 2015
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Flank Pain
• Focal Hepatic Necrosis
• Intracranial Hemorrhages
• Lung Cancer
• Posterior Fossa Hemorrhage
• Urolithiasis

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Duke University Medical Center	Durham	North Carolina
United States	Froedtert Memorial Lutheran Hospital	Miwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
GE Healthcare	American College of Radiology - Image Metrix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence for reduced x-ray radiation exposure for applicable patient indications	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	Yes