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NCT Number: NCT07669727

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

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Therasphere

Device

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

Primary outcomes

  1. Primary Safety Endpoint

    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.

Secondary outcomes

  1. Secondary Safety Endpoint

    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).

  2. Secondary Safety Endpoint

    Time frame: 13 months

    Change from baseline in Albumin Bilirubin (ALBI) score, measured using the ALBI index.

  3. Secondary Safety Endpoint

    Time frame: 13 months

    Most severe grade of hepatotoxicity following radioembolization, assessed using CTCAE grading criteria.

  4. Secondary Effectiveness Endpoint

    Time frame: 13 months

    Objective Response Rate (ORR) as assessed by localized mRECIST criteria.

  5. Secondary Effectiveness Endpoint

    Time frame: 13 months

    Duration of Response (DoR) evaluated by localized mRECIST and mRECIST criteria.

  6. Secondary Effectiveness Endpoint

    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).

  7. Secondary Effectiveness Endpoint

    Time frame: 13 months

    Histopathologic response assessment in patients who undergo surgical resection, collected through descriptive and categorial data points.

  8. Secondary Effectiveness Endpoint

    Time frame: 13 months

    Overall Survival (OS), defined as the time from treatment initiation to death from any cause, measured in months.

Study contacts

Contact information is provided by the study sponsor or research team.

Krista Asmus, MPH

CONTACT

[email protected]

+1 (952) 356-9553

Natalie Lydon, MHA

CONTACT

[email protected]

+1 (612) 240-6364

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Acronym: ADVANCE-MCD

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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