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NCT03196076: CEUS-CKDx

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

Completed Phase 2 Results posted Last updated 21 July 2021
What this trial tests

Phase 2 trial testing Perflutren Lipid microsphere in Chronic Kidney Diseases in 25 participants. Completed in 19 March 2021.

Timeline
28 August 2017
Primary endpoint
19 March 2021
19 March 2021

Quick facts

Lead sponsorUniversity of North Carolina, Chapel Hill
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment25
Start date28 August 2017
Primary completion19 March 2021
Estimated completion19 March 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of North Carolina, Chapel Hill

Who can join

18 and older, any sex, with Chronic Kidney Diseases or Cystic Kidney Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Change in Radiologist's Lesion Evaluation Primary · 1 year

Lesions will be assessed for change in size, calcification, and septation using Bosniak criteria to determine whether a lesion has progressed, regressed or is stable.

GroupValue95% CI
Perflutren Lipid Microsphere (Healthy Subjects)0
Perflutren Lipid Microsphere (Patients With Kidney Lesions)11
Perflutren Lipid Microsphere (Healthy Subjects)0
Perflutren Lipid Microsphere (Patients With Kidney Lesions)1
Perflutren Lipid Microsphere (Healthy Subjects)0
Perflutren Lipid Microsphere (Patients With Kidney Lesions)2
Perflutren Lipid Microsphere (Healthy Subjects)0
Perflutren Lipid Microsphere (Patients With Kidney Lesions)1

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Bubble-Based Drug Delivery Systems: Next-Generation Diagnosis to Therapy.
    Kancheva M, Aronson L, Pattilachan T, Sautto F, et al · · 2023 · cited 16× · PMID 37504868 · DOI 10.3390/jfb14070373

Verify or expand the search:

Other recruiting trials for Chronic Kidney Diseases

Currently open trials in the same condition.

Other University of North Carolina, Chapel Hill trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03196076.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing