COMPLETED

Contrast Enhanced Ultrasound for Renal Obstruction

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Contrast Enhanced Ultrasound for Renal Obstruction

Quick Facts

Study Start:2021-12-03
Study Completion:2025-09-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05090800

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Unilateral renal obstruction confirmed by Nuclear Medicine MAG3 Dynamic Renal Scan (diuretic t (time) ½ \>20 minutes)
  2. * Obstructed kidney with differential function \>15% confirmed by Nuclear Medicine Mercaptoacetyltriglycine (MAG3) Dynamic Renal Scan within less or equal (\<=) 6 months from enrollment
  3. * Patient has elected to move forward with pyeloplasty or proximal ureteroureterostomy to correct the obstruction
  1. * Solitary kidney
  2. * Any abnormalities of contralateral collecting system (for example (e.g.) hydronephrosis, renal calculi, duplicated collecting system)
  3. * Known vesicoureteral reflux
  4. * Ureteral stent in place in the obstructive kidney
  5. * Patients without a Nuclear Medicine MAG3 Dynamic Renal Scan
  6. * Previous history of hypersensitivity to Ultrasound Contrast Agents or Definity (perflutren lipid microspheres))
  7. * Previous sensitivity to polyethylene glycol
  8. * Pregnant or breastfeeding females
  9. * 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)
  10. * Global renal function with a Glomerular Filtration Rate (GFR) \<30 (chronic kidney disease Stage 4 \& 5 excluded)
  11. * Unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, serious ventricular arrhythmias, presence of a cardiac shunt)

Contacts and Locations

Principal Investigator

Sapan N Ambani, MD
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Sapan N Ambani, MD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-03
Study Completion Date2025-09-23

Study Record Updates

Study Start Date2021-12-03
Study Completion Date2025-09-23

Terms related to this study

Keywords Provided by Researchers

  • ultrasound imaging
  • ultrasound contrast agents
  • kidney tissue
  • hydronephrosis

Additional Relevant MeSH Terms

  • Kidney; Obstruction
  • Renal Obstruction