25 Participants Needed

Y-90 Radioembolization for Kidney Cancer

AM
SC
Overseen BySaima Chaabane
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Jonsson Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase I/II trial tests the safety, side effects and effectiveness of radioembolization with yttrium-90 (Y-90) in patients with early stage renal cell carcinoma. Y-90 is a radioactive chemical that is incorporated into millions of very tiny glass spheres. These spheres are injected into the artery that feeds the cancer. This process is called radioembolization. Y-90 radioembolization may be a safe and effective treatment for patients with early stage renal cell carcinoma.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is Y-90 radioembolization generally safe for humans?

Y-90 radioembolization has been used safely in treating liver cancers, with side effects similar to other procedures that involve delivering treatment through the arteries. Some specific side effects include gastrointestinal issues, but methods exist to reduce these risks.12345

How is Y-90 radioembolization treatment different for kidney cancer?

Y-90 radioembolization is unique because it delivers high-dose radiation directly to kidney tumors through tiny beads, minimizing damage to surrounding healthy tissue. This targeted approach is different from traditional treatments like surgery or systemic chemotherapy, which affect the whole body.16789

What data supports the effectiveness of the treatment Yttrium-90 Radioembolization for kidney cancer?

Yttrium-90 radioembolization has shown effectiveness in treating liver cancer and liver metastases from lung cancer, with high tumor response rates and extended patient survival. This suggests potential benefits for kidney cancer, as the treatment involves delivering targeted radiation to tumors, similar to its use in other cancers.110111213

Who Is on the Research Team?

SA

Siddharth A Padia

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with early stage renal cell carcinoma, a type of kidney cancer. Participants should be suitable candidates for the specific artery injection procedure used in this study.

Inclusion Criteria

Negative serum pregnancy test in females of child-bearing potential; patients who are breast-feeding cannot participate in this trial
I do not have tumors in both of my kidneys.
My cancer is too aggressive for just watching and waiting.
See 15 more

Exclusion Criteria

My screening shows my tumor can't be targeted effectively for safe kidney dosing.
I have cancer that has spread to my brain or spinal cord.
I have had a stent in my kidney.
See 18 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Patients undergo radioembolization with yttrium Y 90 glass microspheres (TheraSphere) given intra-arterially

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months
1 day, 1 week, and then monthly

What Are the Treatments Tested in This Trial?

Interventions

  • Yttrium-90 (Y90) Radioembolization
Trial Overview The trial tests Yttrium-90 (Y90) radioembolization safety and effectiveness. It involves injecting tiny radioactive glass spheres into the artery supplying the tumor to see if it's a viable treatment option.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (radioembolization, TheraSphere)Experimental Treatment7 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials
373
Recruited
35,200+

Boston Scientific Corporation

Industry Sponsor

Trials
758
Recruited
867,000+
Michael F. Mahoney profile image

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein profile image

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Published Research Related to This Trial

In a study of 68 patients with unresectable primary liver tumors treated with Yttrium-90 radioembolization at escalated doses (≥150 Gy), the treatment showed promising local control, with a 1-year freedom from local progression rate of 54% for hepatocellular carcinoma (HCC) and 66% for cholangiocarcinoma (CC).
The treatment was found to be safe, with only 7% of patients experiencing grade 3 ascites and 6% experiencing grade 3/4 hyperbilirubinemia, while delivering doses greater than 268 Gy was associated with improved local tumor control in HCC.
Clinical Outcomes of Patients With Unresectable Primary Liver Cancer Treated With Yttrium-90 Radioembolization With an Escalated Dose.Chin, RI., Bommireddy, A., Fraum, TJ., et al.[2022]
In a study involving six pigs, intra-arterial brachytherapy using yttrium-90 (90Y) resin microspheres resulted in a significant reduction in kidney mass (30-70%) and extensive tissue necrosis compared to bland microspheres, indicating a strong localized therapeutic effect.
The 90Y-radioembolization caused notable glomerular atrophy and avascularization near the microspheres, while bland microspheres did not produce similar glomerular changes, highlighting the potential of 90Y for effectively targeting kidney tumors.
Histological Comparison of Kidney Tissue Following Radioembolization with Yttrium-90 Resin Microspheres and Embolization with Bland Microspheres.de Silva, S., Mackie, S., Aslan, P., et al.[2018]
In a study of 42 patients with unresectable liver metastases treated with Yttrium-90 radioembolization, the response rates varied significantly depending on the criteria used, with necrosis criteria showing the highest response rate of 45% and combined criteria at 50%.
PET scans were more effective than CT in detecting treatment responses, identifying 63% of cases compared to only 6% with RECIST criteria, highlighting the potential for PET to improve response assessment in liver cancer treatments.
Response of liver metastases after treatment with yttrium-90 microspheres: role of size, necrosis, and PET.Miller, FH., Keppke, AL., Reddy, D., et al.[2016]

Citations

Clinical Outcomes of Patients With Unresectable Primary Liver Cancer Treated With Yttrium-90 Radioembolization With an Escalated Dose. [2022]
Histological Comparison of Kidney Tissue Following Radioembolization with Yttrium-90 Resin Microspheres and Embolization with Bland Microspheres. [2018]
Response of liver metastases after treatment with yttrium-90 microspheres: role of size, necrosis, and PET. [2016]
Yttrium-90 microsphere radioembolization for treatment of lung cancer hepatic metastases. [2022]
Liver radioembolization using 90Y resin microspheres in elderly patients: tolerance and outcome. [2018]
Side effects of yttrium-90 radioembolization. [2022]
Yttrium-90 Radioembolization: Current Indications and Outcomes. [2023]
Temporary balloon occlusion of the common hepatic artery for administration of yttrium-90 resin microspheres in a patient with patent hepatoenteric collaterals. [2016]
Optimization of radioembolic effect with extended-shelf-life yttrium-90 microspheres: results from a pilot study. [2009]
10.United Statespubmed.ncbi.nlm.nih.gov
Yttrium-90 radioembolization of renal cell carcinoma metastatic to the liver. [2012]
11.United Statespubmed.ncbi.nlm.nih.gov
The effect of catheter-directed CT angiography on yttrium-90 radioembolization treatment of hepatocellular carcinoma. [2005]
12.United Statespubmed.ncbi.nlm.nih.gov
Y90-radioembolization of lung metastases via the bronchial artery: a report of 2 cases. [2017]
Radioembolisation using yttrium 90 (Y-90) in patients affected by unresectable hepatic metastases. [2021]
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