The purpose of this study is to assess the safety and effectiveness of treating a tumor using a different planning method called MCD for the FDA-Approved device, TheraSphere.
TheraSphere Microspheres are microscopic radioactive glass spheres that deliver radiation therapy in the liver tissue where they are placed. This study investigates a procedure called multicompartment dosimetry (MCD). When using a multicompartment dosimetry approach, the doctor will look at images of the liver to see where there is tumor to determine where to treat. That area will be divided into "compartments" where the dose to tumor and the healthy liver are calculated separately. The goal of MCD is to give the tumor a higher radiation dose while protecting more of the healthy part of the liver.
Traditional planning for the TheraSphere Microspheres procedure uses single compartment dosimetry (SCD) which treats the tumor and the healthy liver as one area so the dose is more evenly distributed and the dose to the tumor may be lower than with the MCD approach. The single compartment approach is standard and is well established however this research study is to see if giving TheraSphere Microspheres with an MCD planning method is safe and effective by evaluating the effect of radiation on the liver as well as how the tumor responds to higher doses
TheraSphere Microspheres treatment determined as the optimal therapy
Have unresectable solitary HCC
Treatment Naïve
ECOG 0 or 1
Macrovascular invasion
Extrahepatic metastases
Previous or current ascites/encephalopathy
Previous liver radiation, TACE, or systemic therapy for the disease
Participants will be selected from U.S. centers that are participating in the trial. Patients at these centers who are planning to undergo TheraSphere Microsphere treatment for their hepatocellular carincoma will be considered for this study.
Case-only
Prospective
TheraSphere
DevicePlacement of TheraSphere Microspheres into the area of the primary tumor using multicompartment dosimetry instead of single compartment dosimetry
Primary Safety Endpoint
The rate of Radioembolization Induced Liver Disease (REILD) Grade ≥3 occurring up to 4 months after any TheraSphere Microspheres treatment administration before progression.
Secondary Safety Endpoint
Number of device- and/or procedure-related adverse events (AEs) and serious adverse events (SAEs), measured by count (number of events).
Secondary Safety Endpoint
Change from baseline in Albumin Bilirubin (ALBI) score, measured using the ALBI index.
Secondary Safety Endpoint
Most severe grade of hepatotoxicity following radioembolization, assessed using CTCAE grading criteria.
Secondary Effectiveness Endpoint
Objective Response Rate (ORR) as assessed by localized mRECIST criteria.
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This trial is not recruiting at the moment. You can still explore other options:
