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Contrast Enhanced Ultrasound for Kidney Obstruction

Phase 2
Recruiting
Led By Bryan S Sack, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient has elected to move forward with pyeloplasty or proximal ureteroureterostomy to correct the obstruction
Unilateral renal obstruction confirmed by Nuclear Medicine MAG3 Dynamic Renal Scan (diuretic t (time) ½ >20 minutes)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after contrast injected (approximately 30 minutes)
Awards & highlights

Study Summary

This trial is looking at whether using an ultrasound contrast agent can help show kidney obstruction before and after surgery to fix it.

Who is the study for?
This trial is for individuals with confirmed unilateral kidney obstruction planning surgery to correct it. They must have had a specific renal scan within the last 6 months and not have a solitary kidney, abnormalities in the other kidney, severe allergies to ultrasound contrast agents or certain ingredients, be pregnant/breastfeeding, extremely overweight without prior imaging confirmation, very poor overall kidney function, known reflux into kidneys or an unstable heart condition.Check my eligibility
What is being tested?
The study tests Definity contrast during ultrasound on patients with kidney obstruction before and after their corrective surgery. It aims to evaluate if this FDA-approved agent for liver and heart can also effectively assess kidney obstructions using enhanced imaging techniques.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to the Definity contrast such as shortness of breath, facial swelling or skin reactions. There might also be discomfort at the injection site or unusual sensations during the imaging process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have chosen surgery to fix a blockage in my urinary system.
Select...
My kidney scan shows a blockage in one kidney.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after contrast injected (approximately 30 minutes)
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after contrast injected (approximately 30 minutes) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the curve (AUC) ultrasound measurements
Mean transit time (MTT) ultrasound measurements
Peak intensity (PI) ultrasound measurements
+2 more
Secondary outcome measures
Contrast arrival time (AT) ultrasound measurements
Enhanced slope ultrasound measurements
Fall time (FT) ultrasound measurements
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Definity contrast agentExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,797 Previous Clinical Trials
6,378,048 Total Patients Enrolled
Bryan S Sack, MDPrincipal InvestigatorUniversity of Michigan

Media Library

Definity contrast during ultrasound Clinical Trial Eligibility Overview. Trial Name: NCT05090800 — Phase 2
Kidney Obstruction Research Study Groups: Definity contrast agent
Kidney Obstruction Clinical Trial 2023: Definity contrast during ultrasound Highlights & Side Effects. Trial Name: NCT05090800 — Phase 2
Definity contrast during ultrasound 2023 Treatment Timeline for Medical Study. Trial Name: NCT05090800 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How is Definity contrast administered via ultrasound to treat patients?

"Definity contrast during echocardiography is often utilized to diagnose cardiovascular diseases, enable diagnostic imaging, and facilitate left ventricular imaging."

Answered by AI

How many participants are being recruited for this clinical exploration?

"Affirmative. Clinicaltrials.gov holds records of this trial being posted on December 3rd 2021 and recently edited on the 16th, actively seeking 10 participants from a single medical center for participation."

Answered by AI

Has Definity contrast during ultrasound been granted regulatory approval?

"Definity contrast's safety during an ultrasound was assigned a score of 2 due to existing data which only supports the former and not the latter."

Answered by AI

Does this clinical experiment currently have any openings for participants?

"As of this moment, clinicaltrials.gov reveals that recruitment for this study is ongoing. The trial was initially made visible on December 3rd 2021 and has been amended as recently as the 16th day of the same month."

Answered by AI

Has Definity contrast been utilized for diagnostic purposes in past trials?

"Currently, 19 studies are being conducted to explore Definity contrast during ultrasound. One of these trials is in the final phase 3 stage while the rest have been earlier on in development. The majority of research has taken place at locations in Philadelphia, however 26 other sites across America are also running experiments for this treatment option."

Answered by AI

What goals has this investigation set out to accomplish?

"This trial seeks to assess the Ratio of plateau and peak intensity ultrasound Measurements. Secondary objectives include Final plateau intensity, Contrast arrival time (AT), and Fall time (FT) ultrasound measurements - all with a focus on discerning differences between obstructed and normal kidneys Immediately after contrast injection (approximately 30 minutes)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Contrast Enhanced Ultrasound for Renal Obstruction
Bryan S Sack 2021. "Contrast Enhanced Ultrasound for Renal Obstruction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05090800.
~2 spots leftby Dec 2024
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