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Evaluation of Suspected Liver Pathology in Patients With Contraindications for Contrast Enhanced CT and/or MRI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02651090
Recruitment Status : Withdrawn (Sponsor terminated study before enrollment Sponsor terminated study before enrollment)
First Posted : January 8, 2016
Last Update Posted : September 13, 2017
Information provided by (Responsible Party):
Richard G. Barr MD, PhD, Northeastern Ohio Radiology Research and Education Fund

Brief Summary:
Patients with renal failure or other reason for contraindication for contrast enhanced computed tomography (CECT) or contrast enhanced magnetic resonance imaging (CEMRI) with suspected liver pathology will be evaluated with Sonazoid enhanced Ultrasound

Condition or disease Intervention/treatment Phase
Liver Metastasis Liver Mass Drug: Sonazoid Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Suspected Liver Pathology in Patients With Contraindications for Contrast Enhanced Computed Tomography and/or Magnetic Resonance Imaging Using Sonazoid
Estimated Study Start Date : October 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Arm Intervention/treatment
Experimental: sonazoid
treatment arm with sonazoid
Drug: Sonazoid
Comparison of Sonazoid enhanced ultrasound to non enhanced CT
Other Name: NC100100

Primary Outcome Measures :
  1. The detection rate of Sonozoid enhanced US for focal liver lesions in patients unable to have a contrast enhanced CT or MRI compared to unenhanced CT or MRI [ Time Frame: 2 years ]
    Determination of the liver lesion detection rate of Sonozoid

  2. Focal liver characterization as benign, Indeterminate, or malignant by Sonozoid enhanced ultrasound in compared to unenhanced CT or MRI. [ Time Frame: 2 years ]
    Determine the accuracy of liver lesion characterization by Sonozoid

Secondary Outcome Measures :
  1. Title: Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug, Graded According to NCI CTCAE Version 3.0 [ Time Frame: 2 years ]
    Evaluate the Adverse event rate using Sonozoid

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with a diagnosis of cancer or a high probability of having cancer but not yet diagnosed who have a contraindication to a contrast CT or MRI
  2. Age >18 years
  3. No know allergies to Sonozoid
  4. Ability to give informed consent

Exclusion Criteria:

  1. No IV access
  2. Inability to give informed consent
  3. Pregnancy
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Responsible Party: Richard G. Barr MD, PhD, Medical Director, Northeastern Ohio Radiology Research and Education Fund Identifier: NCT02651090    
Other Study ID Numbers: SONA1
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Richard G. Barr MD, PhD, Northeastern Ohio Radiology Research and Education Fund:
contraindication for CECT
contraindication for CEMRI
liver pathology
renal failure
contrast enhanced ultrasound
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes