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

H. Lee Moffitt Cancer Center and Research Institute1 site in 1 country4 target enrollmentFebruary 19, 2020

ConditionsHepatocellular Carcinoma Liver Cancer

Overview

Phase: Early Phase 1
Intervention: Not specified
Conditions: Hepatocellular Carcinoma
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Enrollment: 4
Locations: 1
Primary Endpoint: Number of Participants with Early Tumor Response
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 19, 2020

End Date

May 14, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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)
•Serum creatinine \< 2.0 mg/dl

Exclusion Criteria

•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

Outcomes

Primary Outcomes

Number of Participants with Early Tumor Response

Time Frame: 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.