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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.

Must not have

Occlusion of the main portal vein

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.

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

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My main portal vein is blocked.

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My bilirubin levels did not significantly increase after Y90 treatment.

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My condition could cause more than 30 Gy radiation to my lungs.

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My scan shows abnormal liver blood flow that can't be fixed with angiography.

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I am allergic to IV dyes used in some imaging tests.

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I cannot receive Theraspheres treatment due to health reasons.

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I cannot undergo radiation therapy due to health reasons.

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I cannot stay still for scans like PET/CT.

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I cannot have a hepatic artery catheter due to blood or vessel issues.

Timeline

Screening ~ 3 weeks3 visits

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.

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.