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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unresectable Hepatocellular Carcinoma | Patients with unresectable hepatocellular carcinoma (HCC) with tumor sizes 1-8cm. Patients will be candidates for TheraSphere Microspheres and planning to undergo the procedure as part of their treatment plan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TheraSphere | Device | Placement of TheraSphere Microspheres into the area of the primary tumor using multicompartment dosimetry instead of single compartment dosimetry |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Safety Endpoint | Number of device- and/or procedure-related adverse events (AEs) and serious adverse events (SAEs), measured by count (number of events). | 13 months |
| Secondary Safety Endpoint |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natalie Lydon, MHA | Contact | +1 (612) 240-6364 | natalie.lydon@bsci.com | |
| Krista Asmus, MPH | Contact | +1 (952) 356-9553 | krista.asmus@bsci.com |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Change from baseline in Albumin Bilirubin (ALBI) score, measured using the ALBI index.
| 13 months |
| Secondary Safety Endpoint | Most severe grade of hepatotoxicity following radioembolization, assessed using CTCAE grading criteria. | 13 months |
| Secondary Effectiveness Endpoint | Objective Response Rate (ORR) as assessed by localized mRECIST criteria. | 13 months |
| Secondary Effectiveness Endpoint | Duration of Response (DoR) evaluated by localized mRECIST and mRECIST criteria. | 13 months |
| Secondary Effectiveness Endpoint | Number of patients who become eligible for liver transplantation or liver resection following treatment, measured by total count (number of patients). | 13 months |
| Secondary Effectiveness Endpoint | Histopathologic response assessment in patients who undergo surgical resection, collected through descriptive and categorial data points. | 13 months |
| Secondary Effectiveness Endpoint | Overall Survival (OS), defined as the time from treatment initiation to death from any cause, measured in months. | 13 months |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |