CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 70 target
Drug / intervention
Yttrium-90 +4 moredrug
Likely dose
Not stated in record
Key inclusion· 8
  • Diagnosis of unresectable hepatocellular carcinoma or metastatic liver cancer
  • HCC defined by biopsy proof or Barcelona imaging criteria
  • Metastatic disease with pathological confirmation and new/enlarging liver lesion
  • No untreated or progressive disease outside the liver
Key exclusion· 10
  • Inability to lie still for imaging studies
  • Pregnancy, nursing, or refusal to use birth control in patients capable of reproduction
  • Known allergy or contraindication to intravenous iodinated contrast agents
  • Allergy or contraindication to MRI contrast (Eovist or Gadolinium)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04518748
NCT04518748Phase 1RecruitingOn TrackUpdated 10mo ago
Long Recruiting

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

University of Michigan Rogel Cancer Center·interventional·Posted Aug 19, 2020·Updated Aug 5, 2025

In Brief

A Phase 1 clinical trial evaluating Yttrium-90, Selective Internal Radiation Therapy, and 3 other interventions for Liver Malignancy. Currently recruiting, targeting 70 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1Recruiting
202120222023202420252026202720282029
First PostedAug 19, 2020
Enrollment StartSep 16, 2020
Primary CompletionMay 1, 2028
Study CompletionNov 1, 2028
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 5.9 years agoPrimary completion in 1.8 years

Interventions

Yttrium-90drug

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

Selective Internal Radiation Therapydevice

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

Stereotactic Body Radiation Therapyradiation

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

PET/CTother

Within 3 hours of completing Y-90 SIRT

Theraspheredevice

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