Contrast Enhanced Ultrasound for Renal Obstruction

Phase 2

Recruiting

• Conditions: Renal Obstruction; Kidney; Obstruction
• Interventions: Drug: Definity contrast during ultrasound

• Registration Number: NCT05090800
• Lead Sponsor: University of Michigan

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-10-11
• Study First Submitted QC: 2021-10-11
• Study First Posted: 2021-10-25
• Study Start: 2021-12-03
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Definity contrast agent	Definity contrast during ultrasound	-

Primary Outcome Measures

Name	Time	Method
Time to peak (TTP) ultrasound measurements	Immediately after contrast injected (approximately 30 minutes)	Differences in ultrasound contrast measurements between obstructed and normal kidneys
Peak intensity (PI) ultrasound measurements	Immediately after contrast injected (approximately 30 minutes)	Differences in ultrasound contrast measurements between obstructed and normal kidneys
Mean transit time (MTT) ultrasound measurements	Immediately after contrast injected (approximately 30 minutes)	Differences in ultrasound contrast measurements between obstructed and normal kidneys
Ratio of plateau and peak intensity ultrasound Measurements	Immediately after contrast injected (approximately 30 minutes)	Differences in ultrasound contrast measurements between obstructed and normal kidneys
Area under the curve (AUC) ultrasound measurements	Immediately after contrast injected (approximately 30 minutes)	Differences in ultrasound contrast measurements between obstructed and normal kidneys

Secondary Outcome Measures

Name	Time	Method
Fall time (FT) ultrasound measurements	Immediately after contrast injected (approximately 30 minutes)	Differences in ultrasound contrast measurements between obstructed and normal kidneys
Enhanced slope ultrasound measurements	Immediately after contrast injected (approximately 30 minutes)	Differences in ultrasound contrast measurements between obstructed and normal kidneys
Initial intrarenal microcirculatory transmit time ultrasound measurements	Immediately after contrast injected (approximately 30 minutes)	Differences in ultrasound contrast measurements between obstructed and normal kidneys
Contrast arrival time (AT) ultrasound measurements	Immediately after contrast injected (approximately 30 minutes)	Differences in ultrasound contrast measurements between obstructed and normal kidneys
Time from peak to baseline (TPB) ultrasound measurements	Immediately after contrast injected (approximately 30 minutes)	Differences in ultrasound contrast measurements between obstructed and normal kidneys
Final plateau intensity ultrasound measurements	Immediately after contrast injected (approximately 30 minutes)	Differences in ultrasound contrast measurements between obstructed and normal kidneys

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States