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Contrast-enhanced Ultrasound for Complex Kidney Lesion Diagnosis in Patients With CKD Extension

NCT03196076 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-07-21

Study results available
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Summary

The purpose of this research study is to evaluate contrast-enhanced ultrasound for kidney malignancies.

Conditions

  • Chronic Kidney Diseases
  • Cystic Kidney Disease

Interventions

DRUG

Perflutren Lipid microsphere

Perflutren will be administered in a bolus or continuous infusion using the dosing range and administration type within the perflutren prescribing information.Once perflutren lipid has been administered, the transducer is maintained in a constant position over the area of interest to show the target lesion in order to assess the enhancement pattern during the early, mid and late vascular phases. Images will also be taken of kidney parenchyma in a suitable longitudinal plane.If there are multiple lesions in one subject requiring a second dose, the subject will have the option to undergo a 2nd contrast-enhanced study 30-minutes after the initial contrast dose, per dosing instructions in the package insert.

Sponsors & Collaborators

  • Lantheus Medical Imaging

    collaborator INDUSTRY

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Emily Chang, M.D. · University of North Carolina Kidney Center 7024 Burnette Womack CB#7155 Chapel Hill,NC 27599-7155

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-28
Primary Completion
2021-03-19
Completion
2021-03-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03196076 on ClinicalTrials.gov