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

NCT04518748 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-08-05

No results posted yet for this study

Summary

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.

Conditions

  • Liver Malignancy

Interventions

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

Sponsors & Collaborators

  • Department of Health and Human Services

    collaborator FED

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

    collaborator NIH

  • University of Michigan Rogel Cancer Center

    lead OTHER

Principal Investigators

  • Kyle Cuneo, MD · University of Michigan Rogel Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-16
Primary Completion
2028-05-31
Completion
2028-11-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04518748 on ClinicalTrials.gov