Clinical trial NCT05090800: Contrast Enhanced Ultrasound for Renal Obstruction
Official title: Contrast Enhanced Ultrasound for Renal Obstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Kidney; Obstruction
Renal Obstruction
Keywords: ultrasound imaging
ultrasound contrast agents
kidney tissue
hydronephrosis
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).


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)

Primary outcomes:
measure: Time to peak (TTP) ultrasound measurements
timeFrame: Immediately after contrast injected (approximately 30 minutes)
measure: Peak intensity (PI) ultrasound measurements
timeFrame: Immediately after contrast injected (approximately 30 minutes)
measure: Mean transit time (MTT) ultrasound measurements
timeFrame: Immediately after contrast injected (approximately 30 minutes)
measure: Area under the curve (AUC) ultrasound measurements
timeFrame: Immediately after contrast injected (approximately 30 minutes)
measure: Ratio of plateau and peak intensity ultrasound Measurements
timeFrame: Immediately after contrast injected (approximately 30 minutes)
Secondary outcomes:
measure: Contrast arrival time (AT) ultrasound measurements
timeFrame: Immediately after contrast injected (approximately 30 minutes)
measure: Enhanced slope ultrasound measurements
timeFrame: Immediately after contrast injected (approximately 30 minutes)
measure: Fall time (FT) ultrasound measurements
timeFrame: Immediately after contrast injected (approximately 30 minutes)
measure: Time from peak to baseline (TPB) ultrasound measurements
timeFrame: Immediately after contrast injected (approximately 30 minutes)
measure: Final plateau intensity ultrasound measurements
timeFrame: Immediately after contrast injected (approximately 30 minutes)
measure: Initial intrarenal microcirculatory transmit time ultrasound measurements
timeFrame: Immediately after contrast injected (approximately 30 minutes)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Sapan N Ambani, MD
role: PRINCIPAL_INVESTIGATOR
References: