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

  • STATUS
    Recruiting
  • End date
    Apr 22, 2023
  • participants needed
    25
  • sponsor
    H. Lee Moffitt Cancer Center and Research Institute
Updated on 22 July 2021
anesthesia
platelet count
measurable disease
carcinoma
serum bilirubin
hepatocellular carcinoma
tumor burden
radioembolization

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.

Details
Condition Adenocarcinoma, HEPATIC NEOPLASM, HEPATOCELLULAR CARCINOMA, Liver Cancer, Malignant Adenoma, Biliary Tract Cancer, cancer, liver, cancer, hepatic, cancer, hepatocellular, liver cancers, liver cell carcinoma
Treatment Lumason®
Clinical Study IdentifierNCT04150874
SponsorH. Lee Moffitt Cancer Center and Research Institute
Last Modified on22 July 2021

Eligibility

Yes No Not Sure

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) 9. 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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