- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03653702
Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)
August 30, 2023 updated by: Richard Lee, Boston Children's Hospital
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.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
70
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nicholas Fisher
- Phone Number: 617-919-2643
- Email: Nicholas.Fisher@childrens.harvard.edu
Study Contact Backup
- Name: Amy Chan
- Phone Number: 617-919-2637
- Email: Amy.chan@childrens.harvard.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Boston Children's Hospital
-
Contact:
- Amy Chan, B.A.
- Phone Number: 347-854-6840
- Email: amy.chan@childrens.harvard.edu
-
Contact:
- Emily Morrison, B.S.
- Phone Number: 617-919-2637
- Email: emily.morrison@childrens.harvard.edu
-
-
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.
Eligibility Criteria
Ages Eligible for Study
6 months to 35 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Contrast Enhanced Ultrasound
Participants will undergo a contrast enhanced ultrasound (CEUS) using 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performance of CEUS result and comparison to DMSA
Time Frame: 3 months after final participant completes participation
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 Major Dates
Study Start (Estimated)
October 1, 2023
Primary Completion (Estimated)
April 1, 2024
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
August 28, 2018
First Submitted That Met QC Criteria
August 28, 2018
First Posted (Actual)
August 31, 2018
Study Record Updates
Last Update Posted (Actual)
August 31, 2023
Last Update Submitted That Met QC Criteria
August 30, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P00027566
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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