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NCT Number: NCT07530172

Radioembolization Versus External Radiation Therapy

The proposed study is a single site, prospective, randomized phase 2 study to evaluate the efficacy and tolerability transarterial radioembolization (TARE) versus stereotactic body radiation therapy (SBRT) for hepatocellular carcinoma. The SBRT arm of the trial will involve standard SBRT delivered over 3-5 fractions as tolerated with dose/total therapy adjusted as needed for safety. The TARE arm of the trial will involve a planning arteriogram followed by selective transarterial delivery of Yttrium-90 into the segmental (≤2) artery supplying the tumor. Administered activity will be an amount prescribed to deliver a dose ≥200 Gy to the perfused tissue. The primary endpoint is the rate of re-treatment of the index lesion over 12 months.

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Key information

Conditions

Heptocellular Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location status: Recruiting

Location contact

Marissa Gilbert

CONTACT

[email protected]

3135568422

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ability to provide written informed consent and HIPAA authorization
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged ≥ 18 years at time of informed consent
  • No more than 3 lesions of HCC evaluated to be eligible for TARE or SBRT at multidisciplinary tumor board
  • Childs-Pugh score ≤ 8
  • ECOG performance status ≤2
  • Adequate organ function defined as:
  • serum bilirubin < 4.0 mg/dL ,
  • albumin > 2 g/dL

Exclusion criteria

  • Any prior SBRT or radioembolization to the target tumor
  • Macrovascular invasion
  • Planned or recommended systemic therapy as consolidation
  • Pregnancy or lactation: Women of childbearing potential must have a negative pregnancy test within 14 days of protocol registration.
  • Known severe allergic reaction (anaphylaxis) to iodinated contrast Coagulopathy that the provider deems would be unsafe for transarterial therapy

Treatment and study plan

Transarterial Radioembolization

Radiation

The TARE arm of the trial will involve a planning arteriogram followed by selective transarterial delivery of Yttrium-90 into the segmental (≤2) artery supplying the tumor. Administered activity will be an amount prescribed to deliver a dose ≥200 Gy to the perfused tissue.

Stereotactic Body Radiation Therapy (SBRT)

Radiation

The SBRT arm of the trial will involve standard SBRT delivered over 3-5 fractions as tolerated with dose/total therapy adjusted as needed for safety.

Primary outcomes

  1. Rate of re-treatment over 12 months

    Time frame: From enrollment to 12 months following the end of treatment

    Rate of re-treatment of the index lesion over 12 months

Secondary outcomes

  1. Laboratory toxicities CBC

    Time frame: From enrollment to 24 months post treatment

    Laboratory CBC (includes WBC (k/uL), RBC (M/uL), and Platelets (K/uL)

  2. Laboratory toxicities CMP

    Time frame: From enrollment to 24 months post treatment

    Laboratory CMP (includes Sodium (mmol/L), Creatine (mg/dL), Total Bilirubin (mg/dL), ALP (IU/L), AST/SGOT (IU/L), ALT/SGPT (IU/L), Serum Albumin (g/dl), INR (unitless), AFP (ng/mL)

  3. Laboratory toxicities INR

    Time frame: From enrollment to 24 months post treatment

    Laboratory INR (unitless)

  4. Laboratory toxicities AFP

    Time frame: From enrollment to 24 months post treatment

    Laboratory AFP (ng/mL)

  5. Clinical toxicities

    Time frame: From enrollment to 24 months post treatment

    Clinical toxicities measured using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Scale of 1 to 5 with 5 being the worst outcome.

  6. Change in Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) version 4.0 from baseline. Scale of 0 to 4 with 4 being the worst outcome.

    Time frame: From enrollment to 1, 3, and 6 months post treatment

    Change in patient reported outcomes

  7. Change in COST: A FACIT Measure of Financial Toxicity (FACIT-COST) version 2.0 from baseline. Scale of 0 to 4 with 4 being the worst outcome.

    Time frame: From enrollment to 1, 3, and 6 months post treatment

    Change in patient reported outcomes

  8. Disease Free Survival

    Time frame: From enrollment to 24 months post treatment

    DFS at 2 years

  9. Local Control

    Time frame: From enrollment to 6 months post treatment

    LC at 6 months after completion of treatment using LIRADS on multiphase CT or MR

  10. Overall Survival

    Time frame: From enrollment to 24 months post treatment

    OS at 2 years

Study contacts

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

Marissa Gilbert

CONTACT

[email protected]

313-556-8422

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Acronym: REVERT

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Apr 15, 2026
Registry last updated
Apr 15, 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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