Status:
COMPLETED
Contrast Enhanced Ultrasound With Lumason in Detecting Liver Cancer in Participants With Cirrhosis
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
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 en...
Detailed Description
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 ul...
Eligibility Criteria
Inclusion
- Able and willing to provide written informed consent
- Diagnosis of cirrhosis based on one or more of the following: histology, US, computed tomography (CT) or MRI showing cirrhosis, +/- lesions seen on CE-MRI
Exclusion
- History of hypersensitivity to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in Lumason
- Pregnant patients-excluded by history
- Pediatric patients, as pediatric cirrhosis is uncommon
Key Trial Info
Start Date :
January 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2020
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03407001
Start Date
January 12 2018
End Date
September 15 2020
Last Update
October 14 2020
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030