Therasphere
DevicePlacement of TheraSphere Microspheres into the area of the primary tumor using multicompartment dosimetry instead of single compartment dosimetry
NCT Number: NCT07669727
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
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Placement of TheraSphere Microspheres into the area of the primary tumor using multicompartment dosimetry instead of single compartment dosimetry
Time frame: 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.
Time frame: 13 months
Number of device- and/or procedure-related adverse events (AEs) and serious adverse events (SAEs), measured by count (number of events).
Time frame: 13 months
Change from baseline in Albumin Bilirubin (ALBI) score, measured using the ALBI index.
Time frame: 13 months
Most severe grade of hepatotoxicity following radioembolization, assessed using CTCAE grading criteria.
Time frame: 13 months
Objective Response Rate (ORR) as assessed by localized mRECIST criteria.
Time frame: 13 months
Duration of Response (DoR) evaluated by localized mRECIST and mRECIST criteria.
Time frame: 13 months
Number of patients who become eligible for liver transplantation or liver resection following treatment, measured by total count (number of patients).
Time frame: 13 months
Histopathologic response assessment in patients who undergo surgical resection, collected through descriptive and categorial data points.
Time frame: 13 months
Overall Survival (OS), defined as the time from treatment initiation to death from any cause, measured in months.
Contact information is provided by the study sponsor or research team.
Krista Asmus, MPH
CONTACT
Natalie Lydon, MHA
CONTACT
Boston Scientific Corporation
Industry
A Post Approval Single-arm Study Evaluating Transarterial Radioembolization Treatment for Hepatocellular Carcinoma Using Multicompartment Dosimetry Planning
Acronym: ADVANCE-MCD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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