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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03653702
Other study ID # P00027566
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date October 1, 2023
Est. completion date June 2024

Study information

Verified date August 2023
Source Boston Children's Hospital
Contact Nicholas Fisher
Phone 617-919-2643
Email Nicholas.Fisher@childrens.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this research study the investigators want to study a safe, radiation-free technique known as contrast-enhanced ultrasound that may improve the ability to diagnose or evaluate renal scarring compared to regular ultrasound. This technique requires injection into a vein of a small amount of contrast material called Lumason. Contrast material is a type of dye that helps the investigators image the structures in the body more clearly. If this technique is successful, the need for DMSA studies may be avoided to diagnose or evaluate kidney scarring. DMSA is a more expensive test, causes radiation exposure, may require sedation and/or injection of contrast agents with the potential to cause allergic reactions.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date June 2024
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender All
Age group 6 Months to 35 Years
Eligibility Inclusion Criteria: - patients older than or equal to 6 months and less than or equal to 35 years old and scheduled for Boston Children's Hospital (BCH) DMSA scan to evaluate renal function and/or renal scarring Exclusion Criteria: - patients with significant congenital renal anatomical abnormalities including horseshoe kidney, kidney malrotation, and multicystic dysplastic kidney (MCDK). Patients with severe cardio-pulmonary diseases will also be excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lumason
Lumason will be used as the contrast agent. Standard Lumason dose will be used: 0.03mL/kg up to a maximum dose of 2.4 milliliter (mL) per injection

Locations

Country Name City State
United States Boston Children's Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Performance of CEUS result and comparison to DMSA DMSA will be used as gold standard to evaluate CEUS test performance. Sensitivity and specificity of CEUS renal scarring detection will be calculated accordingly. Bivariate and multivariate analyses will be completed to compare patient characteristics between those with good and poor CEUS performance to investigate if CEUS performs better in patients with specific covariates 3 months after final participant completes participation
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