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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBoston Scientific Corporation

About this trial

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

Eligibility criteria

Qualifiers

TheraSphere Microspheres treatment determined as the optimal therapy

Have unresectable solitary HCC

Treatment Naïve

ECOG 0 or 1

Disqualifiers

Macrovascular invasion

Extrahepatic metastases

Previous or current ascites/encephalopathy

Previous liver radiation, TACE, or systemic therapy for the disease

Trial design

Treatments tested in this trial

  • TheraSphere

Treatment groups

140 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators