NCT02651090

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_3

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2016

Completed
1.7 years until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

September 13, 2017

Status Verified

September 1, 2017

Enrollment Period

5 months

First QC Date

January 6, 2016

Last Update Submit

September 12, 2017

Conditions

Liver MetastasisLiver Mass

Keywords

contraindication for CECTcontraindication for CEMRIliver pathologyrenal failurecontrast enhanced ultrasoundsonazoid

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (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

    2 years

Study Arms (1)

sonazoid

EXPERIMENTAL

treatment arm with sonazoid

Drug: Sonazoid

Interventions

SonazoidDRUG

Comparison of Sonazoid enhanced ultrasound to non enhanced CT

Also known as: NC100100
sonazoid

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Age \>18 years
  • No know allergies to Sonozoid
  • Ability to give informed consent

You may not qualify if:

  • No IV access
  • Inability to give informed consent
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Sonazoid

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

January 6, 2016

First Posted

January 8, 2016

Study Start

October 1, 2017

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

September 13, 2017

Record last verified: 2017-09