Radioembolization Versus External Radiation Therapy (REVERT)

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.

Study Overview

• Status: Recruiting
• Conditions: Heptocellular Cancer
• Intervention / Treatment: Radiation: Transarterial Radioembolization; Radiation: Stereotactic Body Radiation Therapy (SBRT)

• Study Type: Interventional
• Enrollment (Estimated): 146
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Marissa Gilbert; Phone Number: 313-556-8422; Email: mgilber6@hfhs.org

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Health System
      • Contact: Marissa Gilbert; Phone Number: 3135568422; Email: mgilber6@hfhs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TARE; 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.	Radiation: Transarterial Radioembolization; 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.
Experimental: SBRT; 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.	Radiation: Stereotactic Body Radiation Therapy (SBRT); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of re-treatment over 12 months	Rate of re-treatment of the index lesion over 12 months	From enrollment to 12 months following the end of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laboratory toxicities CBC	Laboratory CBC (includes WBC (k/uL), RBC (M/uL), and Platelets (K/uL)	From enrollment to 24 months post treatment
Laboratory toxicities CMP	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)	From enrollment to 24 months post treatment
Laboratory toxicities INR	Laboratory INR (unitless)	From enrollment to 24 months post treatment
Laboratory toxicities AFP	Laboratory AFP (ng/mL)	From enrollment to 24 months post treatment
Clinical toxicities	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.	From enrollment to 24 months post treatment
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.	Change in patient reported outcomes	From enrollment to 1, 3, and 6 months post treatment
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.	Change in patient reported outcomes	From enrollment to 1, 3, and 6 months post treatment
Disease Free Survival	DFS at 2 years	From enrollment to 24 months post treatment
Local Control	LC at 6 months after completion of treatment using LIRADS on multiphase CT or MR	From enrollment to 6 months post treatment
Overall Survival	OS at 2 years	From enrollment to 24 months post treatment

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Investigators: Principal Investigator: Reena Salgia, MD, Henry Ford Health System

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: March 3, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Therapeutics; Surgical Procedures, Operative; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Radiosurgery
• Other Study ID Numbers: 18805

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No