Contrast Enhanced Ultrasound for Renal Obstruction

Last updated: October 1, 2025
Sponsor: University of Michigan
Overall Status: Completed

Phase

2

Condition

Nephropathy

Treatment

Definity contrast during ultrasound

Clinical Study ID

NCT05090800
HUM00193843
  • Ages > 18
  • All Genders

Study Summary

This research is studying Definity ultrasound contrast agent, which is already approved by the Food and Drug Administration (FDA) for the ultrasound evaluation of the liver and heart. This research will investigate the ability to use ultrasound imaging with ultrasound contrast agents to evaluate kidney obstruction.

Eligible participants that are enrolled will have two visits (one before and one after the planned surgery to relieve the kidney obstruction).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Unilateral renal obstruction confirmed by Nuclear Medicine MAG3 Dynamic Renal Scan (diuretic t (time) ½ >20 minutes)

  • Obstructed kidney with differential function >15% confirmed by Nuclear MedicineMercaptoacetyltriglycine (MAG3) Dynamic Renal Scan within less or equal (<=) 6months from enrollment

  • Patient has elected to move forward with pyeloplasty or proximal ureteroureterostomyto correct the obstruction

Exclusion

Exclusion Criteria:

  • Solitary kidney

  • Any abnormalities of contralateral collecting system (for example (e.g.)hydronephrosis, renal calculi, duplicated collecting system)

  • Known vesicoureteral reflux

  • Ureteral stent in place in the obstructive kidney

  • Patients without a Nuclear Medicine MAG3 Dynamic Renal Scan

  • Previous history of hypersensitivity to Ultrasound Contrast Agents or Definity (perflutren lipid microspheres))

  • Previous sensitivity to polyethylene glycol

  • Pregnant or breastfeeding females

  • Body mass index (BMI) >=40 without prior ultrasound confirming ability to adequatelyvisualize the kidneys (Elevated BMI is known to decrease ability to image thekidneys)

  • Global renal function with a Glomerular Filtration Rate (GFR) <30 (chronic kidneydisease Stage 4 & 5 excluded)

  • Unstable cardiopulmonary conditions (acute myocardial infarction, acute coronaryartery syndromes, worsening or unstable congestive heart failure, seriousventricular arrhythmias, presence of a cardiac shunt)

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Definity contrast during ultrasound
Phase: 2
Study Start date:
December 03, 2021
Estimated Completion Date:
September 23, 2025

Connect with a study center

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

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