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Radioisotope Therapy

Combined Y-90 SIRT + SBRT for Liver Cancer

Phase 1
Recruiting
Led By Kyle Cuneo, MD
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be 18 years of age or older
Patients must not have known untreated extrahepatic cancer.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until death from any cause, or until patient's last follow-up visit, or until study stops; up to approximately 5 years.
Awards & highlights

Study Summary

This trial will study the safety and effectiveness of combining two cancer treatments: Y-90 SIRT and SBRT.

Who is the study for?
This trial is for adults with unresectable hepatocellular carcinoma (liver cancer) that meets specific imaging criteria, has a life expectancy of at least 6 months, and agrees to use contraception. It excludes those who can't stay still for scans, are pregnant or refuse birth control, have certain allergies or contraindications to MRI contrast agents or Theraspheres, high bilirubin levels, main portal vein occlusion, excessive lung shunting from the liver.Check my eligibility
What is being tested?
The study tests combining Y-90 Selective Internal Radiation Therapy (SIRT) with Stereotactic Body Radiation Therapy (SBRT) in treating liver cancer. This approach is being evaluated for safety and side effects; it's also the first time Y-90 PET/CT imaging will be used in planning SBRT.See study design
What are the potential side effects?
Potential side effects may include radiation-related symptoms such as fatigue, skin reactions at treatment sites, abdominal pain or discomfort due to inflammation of liver tissue. There might also be risks associated with internal radiation therapy like nausea and potential damage to nearby organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I do not have untreated cancer outside of my liver.
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My liver cancer cannot be removed with surgery.
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I have been diagnosed with liver cancer through a biopsy.
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My liver tumor meets specific imaging criteria.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until death from any cause, or until patient's last follow-up visit, or until study stops; up to approximately 5 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and until death from any cause, or until patient's last follow-up visit, or until study stops; up to approximately 5 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Child-Turcotte-Pugh (CTP) score >= 2 points from baseline
Incidence of toxicities of grade 3 or higher
Number of patients with a change in albumin + bilirubin (ALBI) level of >= 0.5
Secondary outcome measures
Freedom from local progression (FFLP) at patient level
Freedom from local progression (FFLP) at the lesion level
Overall survival
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Y-90 SIRT followed by SBRTExperimental Treatment5 Interventions
Y-90 SIRT followed by SBRT
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
PET/CT
2022
Completed Phase 3
~1270
Therasphere
2024
N/A
~210

Find a Location

Who is running the clinical trial?

National Institute for Biomedical Imaging and Bioengineering (NIBIB)NIH
89 Previous Clinical Trials
19,683 Total Patients Enrolled
University of Michigan Rogel Cancer CenterLead Sponsor
294 Previous Clinical Trials
24,226 Total Patients Enrolled
4 Trials studying Liver Cancer
869 Patients Enrolled for Liver Cancer
Department of Health and Human ServicesFED
226 Previous Clinical Trials
928,904 Total Patients Enrolled

Media Library

Yttrium-90 (Radioisotope Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04518748 — Phase 1
Liver Cancer Research Study Groups: Y-90 SIRT followed by SBRT
Liver Cancer Clinical Trial 2023: Yttrium-90 Highlights & Side Effects. Trial Name: NCT04518748 — Phase 1
Yttrium-90 (Radioisotope Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04518748 — Phase 1
~23 spots leftby May 2028
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