An Early Phase 1 interventional study of Contrast-Enhanced Ultrasound and Sulfur Hexafluoride Lipid Microspheres in Cirrhosis, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-14.
Sponsored by M.D. Anderson Cancer Center · Early Phase 1, Interventional, and Screening
This early phase I trial studies how well contrast enhanced ultrasound with sulfur hexafluoride lipid microspheres (Lumason) works in detecting liver cancer in participants with cirrhosis. Contrast enhanced-ultrasounds use contrast agents, such as Lumason, that are injected into a vein in order to help certain organs and tissues show up more clearly on scans. Contrast enhanced ultrasound with Lumason may help doctors more easily find liver cancer compared to ultrasounds without contrast agent.
PRIMARY OBJECTIVES:
I. Determine the accuracy of contrast enhanced ultrasound (CEUS) utilizing contrast agent sulfur hexafluoride lipid-type A microspheres compared to B-mode non-contrast enhanced ultrasound for liver lesion detection, including hepatocellular carcinoma (HCC), in cirrhotic ultrasound (US) patients.
SECONDARY OBJECTIVES:
I. Determine the concordance of CEUS vs. contrast enhanced magnetic resonance imaging (CE-MRI) Liver Imaging Reporting and Data Systems (Li-Rads).
OUTLINE:
Within 30 days of routine MRI, participants undergo non-contrast ultrasound of the abdomen. Participants then receive Lumason intravenously (IV) and undergo contrast-enhanced ultrasound of the abdomen over 1 hour.
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This study's enrollment of 9 is below the median of 63 across 840 interventional studies indexed under Fibrosis.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Within 30 days of routine MRI, participants undergo non-contrast ultrasound of the abdomen. Participants then receive Lumason IV and undergo contrast-enhanced ultrasound of the abdomen over 1 hour in the absence of disease progression or unacceptable toxicity.
Procedure: Contrast-Enhanced Ultrasound · Drug: Sulfur Hexafluoride Lipid Microspheres · Procedure: Ultrasound
Undergo CEUS
Also known as: CEUS
Given IV
Also known as: Lumason, SF6 Lipid Microspheres, Sulfur Hexafluoride Lipid-type A Microspheres
Undergo non-contrast US
Accuracy of contrast enhanced ultrasound (CEUS) with contrast agent sulfur hexafluoride lipid-type A microspheres and B-mode non-contrast enhanced ultrasound
The study will estimate the sensitivity of ultrasound (US) and CEUS in patients with detectable lesions on magnetic resonance imaging (MRI). The analysis will be conducted at the patient level with a binary outcome of 0 if the patient has no detectable lesions and 1 if the patient has one or more detectable lesions. The study will use McNemar's test to compare US vs. CEUS in patients with any detectable lesions on MRI. The test assesses whether the two tests have equivalent marginal probabilities (i.e. probability of detecting at least one lesion with US and CEUS is equivalent). McNemar's test statistic depends only on patients where US and CEUS disagree.
Time frame: Up to 3 years
Assessment of CEUS and contrast enhanced magnetic resonance imaging (CE-MRI) Liver Imaging Reporting and Data Systems (Li-Rads)
The study will assess the concordance between CEUS Li-Rads and MRI Li-Rads scoring results for each lesion using a multinomial logit random effects model. The study will summarize the characteristics (the size, location, vascularity and enhancement pattern) of lesions detected by only one imaging modality, stratified by imaging type.
Time frame: Up to 3 years
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sulfur Hexafluoride