Pilot Study of Model Based Iterative Reconstruction Using 64-Slice

NCT01431378 | Terminated

• 1 other identifier: 106-2010-GES-0010
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

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

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GE Healthcare: lead
• American College of Radiology - Image Metrix: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114-2696, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Froedtert Memorial Lutheran Hospital

Miwaukee, Wisconsin, 53226-3596, United States

Location

MeSH Terms

Conditions

Intracranial Hemorrhages; Lung Neoplasms; Flank Pain; Urolithiasis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2011
• First Posted: September 9, 2011
• Study Start: September 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: August 1, 2015
• Last Updated: December 11, 2015

Record last verified: 2015-12

Locations

US (3)