A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning.

Официальное название

A Post Approval Single-arm Study Evaluating Transarterial Radioembolization Treatment for Hepatocellular Carcinoma Using Multicompartment Dosimetry Planning

Обзор

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

Вмешательства

• Устройство TheraSphere
  Placement of TheraSphere Microspheres into the area of the primary tumor using multicompartment dosimetry instead of single compartment dosimetry

Первичные конечные точки

• Primary Safety Endpoint [Срок оценки: 4 months]

Вторичные конечные точки (8)

• Secondary Safety Endpoint [Срок оценки: 13 months]
• Secondary Safety Endpoint [Срок оценки: 13 months]
• Secondary Safety Endpoint [Срок оценки: 13 months]
• Secondary Effectiveness Endpoint [Срок оценки: 13 months]
• Secondary Effectiveness Endpoint [Срок оценки: 13 months]
• Secondary Effectiveness Endpoint [Срок оценки: 13 months]
• Secondary Effectiveness Endpoint [Срок оценки: 13 months]
• Secondary Effectiveness Endpoint [Срок оценки: 13 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07669727 · S10104

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗