Using ultrasound with contrast agents to evaluate kidney obstruction
Contrast Enhanced Ultrasound for Renal Obstruction
This study is testing if a special ultrasound with a contrast agent can help doctors better see and understand kidney blockages in patients who are scheduled for surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT05090800 on ClinicalTrials.gov |
What this trial studies
This research investigates the use of the Definity ultrasound contrast agent, which is FDA-approved for liver and heart evaluations, to assess kidney obstruction. Participants will undergo two visits, one prior to and one after planned surgery to relieve the obstruction. The study aims to determine the effectiveness of ultrasound imaging enhanced with contrast agents in evaluating renal obstruction. The focus is on patients with unilateral renal obstruction confirmed by specific nuclear medicine scans.
Who should consider this trial
Good fit: Ideal candidates are patients with unilateral renal obstruction confirmed by specific imaging tests who are planning to undergo surgery to correct the obstruction.
Not a fit: Patients with a solitary kidney or significant abnormalities in the contralateral collecting system may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive method to better evaluate and manage kidney obstructions.
How similar studies have performed: While the use of ultrasound contrast agents is established in other areas, this specific application for renal obstruction is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Sapan N Ambani, MD — University of Michigan
- Study coordinator: Sapan N Ambani, MD
- Email: sapan@umich.edu
- Phone: 734-936-7030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.