Hepatocellular Carcinoma (HCC)
Conditions
Keywords
Hepatocellular Carcinoma, TheraSphere, multicompartment dosimetry, Radioembolization
Brief summary
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
Interventions
DEVICETheraSphere
Placement of TheraSphere Microspheres into the area of the primary tumor using multicompartment dosimetry instead of single compartment dosimetry
Sponsors
Boston Scientific Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* TheraSphere Microspheres treatment determined as the optimal therapy * Have unresectable solitary HCC * Treatment Naïve * ECOG 0 or 1 * Adequate liver function * Adequate renal and marrow function * Negative pregnancy test and/or adequate contraception for the patient and his/her sexual partner
Exclusion criteria
* Macrovascular invasion * Extrahepatic metastases * Previous or current ascites/encephalopathy * Previous liver radiation, TACE, or systemic therapy for the disease * History of organ allograft including bone marrow * Any significant comorbities or contraindications to TheraSphere
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint | 4 months | The rate of Radioembolization Induced Liver Disease (REILD) Grade ≥3 occurring up to 4 months after any TheraSphere Microspheres treatment administration before progression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Safety Endpoint | 13 months | Number of device- and/or procedure-related adverse events (AEs) and serious adverse events (SAEs), measured by count (number of events). |
| Secondary Effectiveness Endpoint | 13 months | Objective Response Rate (ORR) as assessed by localized mRECIST criteria. |
Contacts
CONTACTNatalie Lydon, MHA
CONTACTKrista Asmus, MPH
Outcome results
None listed