Contrast-Enhanced Ultrasound for the Evaluation of Changes in Tumor Blood Flow Surrounding HAE
- Conditions
- Liver CancerHepatocellular Carcinoma
- Interventions
- Diagnostic Test: Lumason®
- Registration Number
- NCT04150874
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Men and women >18 years of age.
- Histologically or cytologically confirmed hepatocellular carcinoma or meet imaging criteria for a diagnosis of hepatocellular carcinoma with tumor burden dominant in the liver.
- Participants must have measurable disease, by CT or MRI per mRECIST, not be a candidate for surgical resection based on unresectability, anatomy, anesthesia risk, patient preference.
- Serum Bilirubin ≤ 2.0
- Platelet count > 50,000/ul (corrected if needed)
- INR ≤ 1.5 (corrected if needed) 9. Serum creatinine < 2.0 mg/dl
- Participants must be at least one month beyond prior chemotherapy, ablation or surgery, and have recovered from all therapy-associated toxicities.
- History of severe allergic reaction to intravenous contrast media (iodinated and gadoliniumbased) or any agents used during the embolization; participant cannot be medicated against allergic reaction prior to embolization or contrast enhanced ultrasound.
- History of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in Lumason® microbubbles
- Active infection
- Participants with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias)
- Pregnancy or lactation. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- Participants may not be receiving any other investigational agents
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lumason Microbubbles Lumason® Participants will receive an IV administrative of Lumason® microbubbles, prior to radioembolization. 2 doses of 2.5mL will be administered
- Primary Outcome Measures
Name Time Method Number of Participants with Early Tumor Response Base line up to 24 weeks Dynamic CEUS imaging will demonstrate perfusion characteristics that will predict early tumor response to Transarterial Y90 embolization in Hepatocellular Carcinoma. A change in intra-tumoral arterial flow will be predictive of early response. This will be evaluated immediately following hepatic artery embolization (day 0), at 4 weeks (follow-up 1), 12 weeks (follow-up 2) and 24 weeks (follow-up 3). A modified RECIST will be used to measure early tumor response.
- Secondary Outcome Measures
Name Time Method Number of Participants with Early Signs of Radiation Induced Liver Disease (RILD) Base line up to 24 weeks Dynamic CEUS imaging will demonstrate perfusion characteristics that will predict early signs of Radiation Induced Liver Disease (RILD) after Transarterial Y90 embolization in Hepatocellular Carcinoma. This will be evaluated immediately following hepatic artery embolization (day 0), at 4 weeks (follow-up 1), 12 weeks (follow-up 2) and 24 weeks (follow-up 3).
Trial Locations
- Locations (1)
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States