Contrast-Enhanced Ultrasound for Kidney Cancer Subtyping and Staging

PHASE2CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

October 7, 2020

Primary Completion Date

August 5, 2022

Study Completion Date

August 5, 2022

Conditions
Kidney Cancer
Interventions
DRUG

Perflutren lipid microsphere

Baseline B-mode US will be performed to confirm the lesions being imaged (unless it is a subject with no lesions, then a basic B-mode US will be performed. Perflutren is a diagnostic drug that is intended to be used for contrast enhancement. The vial contains a clear, colorless, sterile, non-pyrogenic, hypertonic solution which is activated by mechanical agitation with Vialmix®.It will be dispensed in inactivated form to a study team member. The contrast agent will be activated just prior to administration (ideally to be used within 5 minutes of activation). Contrast agent Definity (or Lumason) will be activated according to package insert instructions, including use of VialMix®, the device used to activate Definity. Administration will occur IV in coordination with sonography staff trained specifically in contrast ultrasound imaging.The total imaging time is anticipated to be less than 30 minutes.

DRUG

Sulfur hexafluoride lipid microspheres

Baseline B-mode US will be performed to confirm the lesions being imaged (unless it is a subject with no lesions, then a basic B-mode US will be performed. Lumason will be used as a secondary contrast agent only if Definity(perflutren) is unavailable.This drug will be administered using the dosing range and administration type within the Lumason prescribing information. The contrast agent will be activated just prior to administration (ideally to be used within 5 minutes of activation). Contrast agent Definity (or Lumason) will be activated according to package insert instructions, including use of VialMix®, the device used to activate Definity. Administration will occur IV in coordination with sonography staff trained specifically in contrast ultrasound imaging.The total imaging time is anticipated to be less than 30 minutes.

Trial Locations (1)

27599

University of North Carolina at Chapel Hill, Chapel Hill

All Listed Sponsors
lead

UNC Lineberger Comprehensive Cancer Center

OTHER

NCT04021238 - Contrast-Enhanced Ultrasound for Kidney Cancer Subtyping and Staging | Biotech Hunter | Biotech Hunter