A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning.
ADVANCE-MCD
A Post Approval Single-arm Study Evaluating Transarterial Radioembolization Treatment for Hepatocellular Carcinoma Using Multicompartment Dosimetry Planning
1 other identifier
observational
140
0 countries
N/A
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2026
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2026
CompletedFirst Posted
Study publicly available on registry
June 25, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2029
July 31, 2026
July 1, 2026
1.8 years
May 29, 2026
July 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (8)
Secondary Safety Endpoint
13 months
Secondary Safety Endpoint
13 months
Secondary Safety Endpoint
13 months
Secondary Effectiveness Endpoint
13 months
Secondary Effectiveness Endpoint
13 months
- +3 more secondary outcomes
Study Arms (1)
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.
Interventions
Placement of TheraSphere Microspheres into the area of the primary tumor using multicompartment dosimetry instead of single compartment dosimetry
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2026
First Posted
June 25, 2026
Study Start
August 1, 2026
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2029
Last Updated
July 31, 2026
Record last verified: 2026-07