Contrast-Enhanced Ultrasound for the Evaluation of Changes in Tumor Blood Flow Surrounding HAE (NCT04150874) | Clinical Trial Compass
TerminatedEarly Phase 1
Contrast-Enhanced Ultrasound for the Evaluation of Changes in Tumor Blood Flow Surrounding HAE
Stopped: Slow Accrual
United States4 participantsStarted 2020-02-19
Plain-language summary
The purpose of the study is to find out if a study agent called LumasonĀ® 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.
Who can participate
Age range18 Years
SexALL
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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 LumasonĀ® microbubbles
* Active infection
* Participants with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or seriousā¦
What they're measuring
1
Number of Participants with Early Tumor Response
Timeframe: Base line up to 24 weeks
Trial details
NCT IDNCT04150874
SponsorH. Lee Moffitt Cancer Center and Research Institute