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Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)

Primary Purpose

Vesico-Ureteral Reflux

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lumason
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Vesico-Ureteral Reflux

Eligibility Criteria

6 Months - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Boston Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Contrast Enhanced Ultrasound

Arm Description

Participants will undergo a contrast enhanced ultrasound (CEUS) using Lumason

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 28, 2018
Last Updated
August 30, 2023
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03653702
Brief Title
Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)
Official Title
Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vesico-Ureteral Reflux

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Contrast Enhanced Ultrasound
Arm Type
Experimental
Arm Description
Participants will undergo a contrast enhanced ultrasound (CEUS) using Lumason
Intervention Type
Drug
Intervention Name(s)
Lumason
Intervention Description
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
Primary Outcome Measure Information:
Title
Performance of CEUS result and comparison to DMSA
Description
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
Time Frame
3 months after final participant completes participation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicholas Fisher
Phone
617-919-2643
Email
Nicholas.Fisher@childrens.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Chan
Phone
617-919-2637
Email
Amy.chan@childrens.harvard.edu
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Chan, B.A.
Phone
347-854-6840
Email
amy.chan@childrens.harvard.edu
First Name & Middle Initial & Last Name & Degree
Emily Morrison, B.S.
Phone
617-919-2637
Email
emily.morrison@childrens.harvard.edu

12. IPD Sharing Statement

Learn more about this trial

Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)

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