Contrast Enhanced Ultrasound for Renal Obstruction

NCT ID: NCT05090800

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-03
• Study Completion Date: 2025-09-23

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Definity contrast agent

Group Type: EXPERIMENTAL

Definity contrast during ultrasound

Intervention Type: 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.

Interventions

Definity contrast during ultrasound

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.

Intervention Type: DRUG

Other Intervention Names

Perflutren Lipid Microsphere

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Sapan Ambani

Associate Professor of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sapan N Ambani, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00193843

Identifier Type: -

Identifier Source: org_study_id