NCT04150874

Contrast-Enhanced Ultrasound for the Evaluation of Changes in Tumor Blood Flow Surrounding HAE

Contrast-Enhanced Ultrasound for the Evaluation of Changes in Tumor Blood Flow and the Surrounding Hepatic Parenchyma Before, During and After Hepatic Artery Embolization

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to find out if a study agent called Lumason® microbubbles may be helpful for people with lesions in the liver. It is possible it may help determine an early response to radioembolization and/or help demonstrate radiation toxicity to the surrounding liver.

Conditions

• Hepatocellular Carcinoma
• Liver Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Lumason®	Hepatic artery embolization using standard of care radioembolization and assessment of tumor and hepatic parenchymal perfusion kinetics before, during and after treatment with standard of care iodinated contrast (at the time of Y90 radioembolization treatment) and standard of care follow-up with multiphase CT or MRI with the addition of study agent Lumason microbubbles for contrast-enhanced ultrasound (which will be performed concurrently with standard evaluation).

Timeline

• Start date: 2020-02-19
• Primary completion: 2021-05-14
• Completion: 2021-05-14
• First posted: 2019-11-05
• Last updated: 2023-04-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study