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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 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.

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

~1240

Therasphere

2024

N/A

~210

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute for Biomedical Imaging and Bioengineering (NIBIB)NIH

89 Previous Clinical Trials

19,706 Total Patients Enrolled

University of Michigan Rogel Cancer CenterLead Sponsor

294 Previous Clinical Trials

24,216 Total Patients Enrolled

4 Trials studying Liver Cancer

866 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are involved in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this study is still recruiting volunteers and has been since it was posted on September 16th 2020. The investigation is aiming to enlist 45 patients at a single medical location before the December 2021 update date."

Answered by AI

What further examinations have been conducted regarding Stereotactic Body Radiation Therapy?

"Currently, there are six trials that are ongoing and investigating the efficacy of Stereotactic Body Radiation Therapy with one trial in Phase 3. The bulk of the studies for this therapy take place in Ann Arbor, Michigan; however, 6 other locations have begun investigations into its potential uses."

Answered by AI

What outcomes are researchers hoping to observe from this clinical trial?

"This trial's primary objective is to measure a change in the Child-Turcotte-Pugh (CTP) score of two points or greater following Stereotactic Body Radiation Therapy (SBRT). Secondary endpoints encompass Freedom From Local Progression (FFLP) at both patient and lesion level, as well as Overall Survival. All outcomes are determined based on RECIST v1.1and mRECIST criteria over an approximate 6 month follow up period."

Answered by AI

Is there an ongoing enrollment period for this experiment?

"According to clinicaltrials.gov, this medical examination is presently recruiting participants. The trial was initially advertised on September 16th 2020 and the most recent update occurred on December 16th 2021."

Answered by AI

Has Stereotactic Body Radiation Therapy attained authorization from the Federal Drug Administration?

"Based on our internal risk assessment, Stereotactic Body Radiation Therapy's safety was scored as a one since it is currently in the preliminary stages of clinical testing with few results attesting to its efficacy and security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Combined Y-90 Selective Internal Radiation Therapy (Y-90 SIRT) and Stereotactic Body Radiation Therapy (SBRT) in Hepatic Malignancy.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04518748.

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