Combined Y-90 Selective Internal Radiation Therapy (Y-90 SIRT) and Stereotactic Body Radiation Therapy (SBRT) in Hepatic Malignancy.

A Phase 1 Study of Combined Y-90 Selective Internal Radiation Therapy (Y-90 SIRT) and Stereotactic Body Radiation Therapy (SBRT) in Hepatic Malignancy.

Combined Y-90 Selective Internal Radiation Therapy (Y-90 SIRT) and Stereotactic Body Radiation Therapy (SBRT) in Hepatic Malignancy. (NCT04518748) is a Phase 1 interventional studying Liver Malignancy, sponsored by University of Michigan Rogel Cancer Center. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

This study will investigate the combination of Ytrium-90 (Y-90) Selective Internal Radiation Therapy (SIRT) followed by Stereotactic Body Radiation Therapy (SBRT). Y-90 SIRT alone or SBRT alone are standard procedures used in the treatment of liver cancer. This study will assess the combination of Y-90 SIRT and SBRT and obtain preliminary information about the side effects and safety of the combination therapy. Additionally, this is the first time that Y-90 PET-CT imaging will be included in planning for SBRT.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Liver Malignancy, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 70 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Liver Malignancy subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Diagnosis of unresectable hepatocellular carcinoma or metastatic liver cancer. Hepatocellular carcinoma is defined as having at least one of the following: - Biopsy proven hepatocellular carcinoma (HCC); or - A discrete hepatic tumor(s) as defined by the Barcelona imaging criteria. Metastatic liver cancer is defined as having: o pathological confirmation of any metastatic disease with a new or enlarging liver lesion consistent with metastases. The targeted lesion does not need to be biopsied if the patient has a known history of metastatic disease - Patients must not have known untreated or progressive disease outside of the liver - At least one lesion \>2 cm diameter or 4 cc volume - Patients must have a expected to live at least 6 months. - Patients must be 18 years of age or older - All men, as well as women of childbearing potential, must agree to use effective contraception throughout the study and for 90 days following treatment. - Patients must understand and be willing to sign an willing to sign a consent form form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks. Who Should NOT Join This Trial: - Inability to lie still for imaging studies (e.g. PET/CT) - Pregnancy or nursing females or refusal to use birth control in patients capable of reproduction. - Patients with known allergy or contraindication to intravenous iodinated contrast agents - Patients with an allergy or contraindication to MRI on MRI contrast (Eovist or Gadolinium) - Contraindication to Theraspheres - Tc-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphy showing any deposition to the gastrointestinal tract that may not be corrected by angiographic techniques - Shunting of blood to the lungs that could result in delivery of greater than 30 Gy to the lungs. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Diagnosis of unresectable hepatocellular carcinoma or metastatic liver cancer. Hepatocellular carcinoma is defined as having at least one of the following: * Biopsy proven hepatocellular carcinoma (HCC); or * A discrete hepatic tumor(s) as defined by the Barcelona imaging criteria. Metastatic liver cancer is defined as having: o pathological confirmation of any metastatic disease with a new or enlarging liver lesion consistent with metastases. The targeted lesion does not need to be biopsied if the patient has a known history of metastatic disease * Patients must not have known untreated or progressive disease outside of the liver * At least one lesion \>2 cm diameter or 4 cc volume * Patients must have a life expectancy of at least 6 months. * Patients must be 18 years of age or older * All men, as well as women of childbearing potential, must agree to use effective contraception throughout the study and for 90 days following treatment. * Patients must understand and be willing to sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks. Exclusion Criteria: * Inability to lie still for imaging studies (e.g. PET/CT) * Pregnancy or nursing females or refusal to use birth control in patients capable of reproduction. * Patients with known allergy or contraindication to intravenous iodinated contrast agents * Patients with an allergy or contraindication to MRI on MRI contrast (Eovist or Gadolinium) * Contraindication to Theraspheres * Tc-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphy showing any deposition to the gastrointestinal tract that may not be corrected by angiographic techniques * Shunting of blood to the lungs that could result in delivery of greater than 30 Gy to the lungs. * Hepatic artery catheterization contraindication; such as patients with vascular abnormalities or bleeding diathesis; * Bilirubin \>2.0 at baseline * Occlusion of the main portal vein * Contraindication to radiation therapy * Note: Patients who have an increase in bilirubin \>1.0 from the time of Y90 to SBRT or his/her bilirubin goes above 2.5 after Y90 will not be eligible for SBRT.

Treatments Being Tested

DRUG

Yttrium-90

Radioactive isotope Y-90 at day 0, administered by selective internal radiation therapy (SIRT)

DEVICE

Selective Internal Radiation Therapy

SIRT at day 0, to administer Yttrium-90 (Y-90) Theraspheres

RADIATION

Stereotactic Body Radiation Therapy

3-5 fractions over 1-2 weeks, after Y-90 SIRT

DIAGNOSTIC_TEST

PET/CT

Within 3 hours of completing Y-90 SIRT

DEVICE

Therasphere

Glass microspheres containing Y-90, administered at day 0 by SIRT

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04518748), the sponsor (University of Michigan Rogel Cancer Center), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04518748 clinical trial studying?

Who can participate in NCT04518748?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04518748?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04518748. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04518748. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.