Contrast Enhanced Ultrasound for Renal Obstruction

NCT05090800 | Completed Phase 2 FDA Drug

• 1 other identifier: HUM00193843
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Kidney; Obstruction; Renal Obstruction

Keywords

ultrasound imaging; ultrasound contrast agents; kidney tissue; hydronephrosis

Outcome Measures

Primary Outcomes (5)

• Time to peak (TTP) ultrasound measurements

  Differences in ultrasound contrast measurements between obstructed and normal kidneys

  Immediately after contrast injected (approximately 30 minutes)

• Peak intensity (PI) ultrasound measurements

  Differences in ultrasound contrast measurements between obstructed and normal kidneys

  Immediately after contrast injected (approximately 30 minutes)

• Mean transit time (MTT) ultrasound measurements

  Differences in ultrasound contrast measurements between obstructed and normal kidneys

  Immediately after contrast injected (approximately 30 minutes)

• Area under the curve (AUC) ultrasound measurements

  Differences in ultrasound contrast measurements between obstructed and normal kidneys

  Immediately after contrast injected (approximately 30 minutes)

• Ratio of plateau and peak intensity ultrasound Measurements

  Differences in ultrasound contrast measurements between obstructed and normal kidneys

  Immediately after contrast injected (approximately 30 minutes)

Secondary Outcomes (6)

• Contrast arrival time (AT) ultrasound measurements

  Immediately after contrast injected (approximately 30 minutes)

• Enhanced slope ultrasound measurements

  Immediately after contrast injected (approximately 30 minutes)

• Fall time (FT) ultrasound measurements

  Immediately after contrast injected (approximately 30 minutes)

• Time from peak to baseline (TPB) ultrasound measurements

  Immediately after contrast injected (approximately 30 minutes)

• Final plateau intensity ultrasound measurements

  Immediately after contrast injected (approximately 30 minutes)

Study Arms (1)

Definity contrast agent

EXPERIMENTAL

Drug: Definity contrast during ultrasound

Interventions

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.

Also known as: Perflutren Lipid Microsphere

Definity contrast agent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Bites and Stings; Hydronephrosis

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Sapan N Ambani, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Urology

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 25, 2021
• Study Start: December 3, 2021
• Primary Completion: September 23, 2025
• Study Completion: September 23, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)