Liver Metastasis Clinical Trial
Official title:
Evaluation of Suspected Liver Pathology in Patients With Contraindications for Contrast Enhanced Computed Tomography and/or Magnetic Resonance Imaging Using Sonazoid
Verified date | September 2017 |
Source | Northeastern Ohio Radiology Research and Education Fund |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Northeastern Ohio Radiology Research and Education Fund |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Determination of the liver lesion detection rate of Sonozoid | 2 years | |
Primary | Focal liver characterization as benign, Indeterminate, or malignant by Sonozoid enhanced ultrasound in compared to unenhanced CT or MRI. | Determine the accuracy of liver lesion characterization by Sonozoid | 2 years | |
Secondary | 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 | Evaluate the Adverse event rate using Sonozoid | 2 years |
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