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Not yet recruiting NCT07669727

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

— Observational Hepatocellular Carcinoma (HCC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TheraSphere.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma (HCC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Primary outcome measures

  • Primary Safety Endpoint [Time frame: 4 months]
Secondary outcome measures (8)
  • Secondary Safety Endpoint [Time frame: 13 months]
  • Secondary Safety Endpoint [Time frame: 13 months]
  • Secondary Safety Endpoint [Time frame: 13 months]
  • Secondary Effectiveness Endpoint [Time frame: 13 months]
  • Secondary Effectiveness Endpoint [Time frame: 13 months]
  • Secondary Effectiveness Endpoint [Time frame: 13 months]
  • Secondary Effectiveness Endpoint [Time frame: 13 months]
  • Secondary Effectiveness Endpoint [Time frame: 13 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07669727 · S10104

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗