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OpenTrials
Completed

NCT Number: NCT05090800

Contrast Enhanced Ultrasound for Renal Obstruction

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).

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Key information

Conditions

Kidney; Obstruction Bites and Stings Chemically-Induced Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hydronephrosis Kidney Diseases Male Urogenital Diseases Poisoning Renal Obstruction Urogenital Diseases Urologic Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 Medicine Mercaptoacetyltriglycine (MAG3) Dynamic Renal Scan within less or equal (<=) 6 months from enrollment
  • Patient has elected to move forward with pyeloplasty or proximal ureteroureterostomy to correct the obstruction

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 adequately visualize the kidneys (Elevated BMI is known to decrease ability to image the kidneys)
  • Global renal function with a Glomerular Filtration Rate (GFR) <30 (chronic kidney disease Stage 4 & 5 excluded)
  • Unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, serious ventricular arrhythmias, presence of a cardiac shunt)

Treatment and study plan

Definity contrast during ultrasound

Drug

Participants will undergo an ultrasound contrast evaluation of both kidneys. This will include placement of an intravenous (IV) catheter in a vein and the delivery of Definity ultrasound contrast agent through the IV. Imaging will be completed for each kidney. The proposed total dose for adult patients will not exceed 20 microliters/kilograms (kg). Each individual dose not to exceed 10 microliters/kg. At initiation of patient studies, the dose will start at 10 microliters/kg for the first injection and a second 10 microliters/kg dose to evaluate the contralateral kidney. However, if ultrasound findings in patient studies demonstrate a dose that is too high (unable to make accurate ultrasound assessment), the dose will be reduced.

Other names: Perflutren Lipid Microsphere

Primary outcomes

  1. Time to peak (TTP) ultrasound measurements

    Time frame: Immediately after contrast injected (approximately 30 minutes)

    Differences in ultrasound contrast measurements between obstructed and normal kidneys

  2. Peak intensity (PI) ultrasound measurements

    Time frame: Immediately after contrast injected (approximately 30 minutes)

    Differences in ultrasound contrast measurements between obstructed and normal kidneys

  3. Mean transit time (MTT) ultrasound measurements

    Time frame: Immediately after contrast injected (approximately 30 minutes)

    Differences in ultrasound contrast measurements between obstructed and normal kidneys

  4. Area under the curve (AUC) ultrasound measurements

    Time frame: Immediately after contrast injected (approximately 30 minutes)

    Differences in ultrasound contrast measurements between obstructed and normal kidneys

  5. Ratio of plateau and peak intensity ultrasound Measurements

    Time frame: Immediately after contrast injected (approximately 30 minutes)

    Differences in ultrasound contrast measurements between obstructed and normal kidneys

Secondary outcomes

  1. Contrast arrival time (AT) ultrasound measurements

    Time frame: Immediately after contrast injected (approximately 30 minutes)

    Differences in ultrasound contrast measurements between obstructed and normal kidneys

  2. Enhanced slope ultrasound measurements

    Time frame: Immediately after contrast injected (approximately 30 minutes)

    Differences in ultrasound contrast measurements between obstructed and normal kidneys

  3. Fall time (FT) ultrasound measurements

    Time frame: Immediately after contrast injected (approximately 30 minutes)

    Differences in ultrasound contrast measurements between obstructed and normal kidneys

  4. Time from peak to baseline (TPB) ultrasound measurements

    Time frame: Immediately after contrast injected (approximately 30 minutes)

    Differences in ultrasound contrast measurements between obstructed and normal kidneys

  5. Final plateau intensity ultrasound measurements

    Time frame: Immediately after contrast injected (approximately 30 minutes)

    Differences in ultrasound contrast measurements between obstructed and normal kidneys

  6. Initial intrarenal microcirculatory transmit time ultrasound measurements

    Time frame: Immediately after contrast injected (approximately 30 minutes)

    Differences in ultrasound contrast measurements between obstructed and normal kidneys

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Oct 25, 2021
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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