30
Participants
Start Date
September 11, 2025
Primary Completion Date
June 30, 2027
Study Completion Date
June 30, 2027
Lumason
Following baseline ultrasound imaging, CEUS will be performed using dual B-mode and CEUS mode. For the first injection using Lumason the approximate tumor mid-line will be imaged during breath hold until complete tumor enhancement is achieved followed by imaging sweeps through the tumor. Intermittent imaging will be performed after that. Following a 10 minute Lumason wash-out period, participants will then receive a bolus injection of Sonazoid with identical imaging protocol to Lumason for the first 60 seconds to evaluate arterial phase enhancement. Imaging sweeps of the tumor will then be obtained at 1 and 2 minutes to evaluate enhancement within the late vascular phase to detect early washout. After visualization in the late phase, imaging will resume to evaluate the Kupffer phase of contrast enhancement. Following completion of the exam, patients will be monitored for at least 30 minutes before being discharged and all data will be exported for later off-line analysis
Sonazoid
Participants will receive a bolus injection up to (0.12 µl of MB/kg) of Sonazoid, followed by 5-10 ml of normal saline. Imaging of Sonazoid will be identical to the protocol described above for the first 60 seconds to evaluate arterial phase enhancement. Imaging sweeps (5-10 seconds) of the tumor will then be obtained in at 1 and 2 minutes to evaluate enhancement within the late vascular phase and detect early washout. After that imaging will resume to evaluate the Kupffer phase of contrast enhancement. Kupffer phase imaging (also called the postvascular phase) starts approximately 8-10 mins after injection when the free circulating microbubbles have been eliminated from the vasculature with Kupfer-cell enhancement persisting for up to 2 hours. Sonazoid CEUS will be performed in all patients after Lumason clearance from the circulation, usually within 15 min after injection.
RECRUITING
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, Philadelphia
National Cancer Institute (NCI)
NIH
Thomas Jefferson University
OTHER