NCT07530172 Radioembolization Versus External Radiation Therapy
| NCT ID | NCT07530172 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Henry Ford Health System |
| Condition | Heptocellular Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 146 participants |
| Start Date | 2025-12-08 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 146 participants in total. It began in 2025-12-08 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Reena Salgia, MD
PRINCIPAL INVESTIGATOR
Henry Ford Health System
Frequently Asked Questions
Who can join the NCT07530172 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heptocellular Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07530172 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07530172 currently recruiting?
Yes, NCT07530172 is actively recruiting participants. Contact the research team at mgilber6@hfhs.org for enrollment information.
Where is the NCT07530172 trial being conducted?
This trial is being conducted at Detroit, United States.
Who is sponsoring the NCT07530172 clinical trial?
NCT07530172 is sponsored by Henry Ford Health System. The principal investigator is Reena Salgia, MD at Henry Ford Health System. The trial plans to enroll 146 participants.
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