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Clinical Trial 19974

Cancer Type: Gastrointestinal Tumor
Interventions:

Study Type: Diagnostic
Phase of Study: N/A
Investigators:

  • Melissa McGettigan

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

Contrast-Enhanced Ultrasound for the Evaluation of Changes in Tumor Blood Flow and the Surrounding Hepatic Parenchyma before, during and after Hepatic Artery Embolization

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.

Objective

Primary Objective: Prospectively acquire contrast-enhanced ultrasound (CEUS) scans following intravenous (IV) administration of Lumason® microbubbles in 25 patients with primary tumors in the liver. Secondary Objectives: Quantitative analysis of CEUS to predict tumor response to and liver toxicity from HAE.

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, participant 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