Y-90 Radioembolization for Kidney Cancer
Recruiting in Palo Alto (17 mi)
Overseen bySiddharth A Padia
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Jonsson Comprehensive Cancer Center
Disqualifiers: Metastases, Prior radiation, Active infection, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
26789How 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.
210111213Eligibility Criteria
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.
+16 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.
+18 more
Trial Timeline
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Treatment (radioembolization, TheraSphere)Experimental Treatment7 Interventions
Patients undergo radioembolization with TheraSphere given intra-arterially. Patients undergo angiogram during screening, SPECT scan on study and CT scan and blood sample collection throughout the study.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, CA
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Who Is Running the Clinical Trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
Boston Scientific CorporationIndustry Sponsor
References
Clinical Outcomes of Patients With Unresectable Primary Liver Cancer Treated With Yttrium-90 Radioembolization With an Escalated Dose. [2022]Yttrium-90 (90Y) radioembolization with an escalated dose has been shown to improve clinical outcomes compared with standard dose radioembolization, but there are few data on the local control of primary liver tumors. We reported the clinical outcomes of patients with unresectable primary liver tumors treated with 90Y radioembolization with an escalated dose.
Histological Comparison of Kidney Tissue Following Radioembolization with Yttrium-90 Resin Microspheres and Embolization with Bland Microspheres. [2018]Label="BACKGROUND" NlmCategory="BACKGROUND">Intra-arterial brachytherapy with yttrium-90 (90Y) resin microspheres (radioembolization) is a procedure to selectively deliver high-dose radiation to tumors. The purpose of this research was to compare the radioembolic effect of 90Y-radioembolization versus the embolic effect of bland microspheres in the porcine kidney model.
Response of liver metastases after treatment with yttrium-90 microspheres: role of size, necrosis, and PET. [2016]Yttrium-90 radioembolization is an emerging treatment for liver malignancies. The purpose of this study was to evaluate the imaging response of liver metastases to 90Y microspheres based on size and necrosis criteria using CT and comparing the results to PET and to describe imaging features related to 90Y therapy.
Yttrium-90 microsphere radioembolization for treatment of lung cancer hepatic metastases. [2022]Because stage 4 lung cancer is associated with dismal 5-year survival rates, new treatment approaches targeting extrapulmonary disease are necessary. Yttrium-90 microsphere radioembolization is an emerging treatment for metastatic hepatic malignancies that results in high tumor response rates and extended patient survival. To date, application of this therapy toward management of lung cancer hepatic metastases has not been extensively described. Herein, we present 2 cases of effective yttrium-90 radioembolization for treatment of lung cancer hepatic metastases, and emphasize the potential coadjuvant value of this procedure in patients with advanced-stage lung cancer and liver-dominant metastatic disease.
Liver radioembolization using 90Y resin microspheres in elderly patients: tolerance and outcome. [2018]Yttrium 90 (90Y) microsphere radioembolization (90Y-RE) is an emerging locoregional treatment for liver cancer. The most common complications of 90Y-RE arise from excessive irradiation of nontarget organs (eg, gastrointestinal tract, lung, and nontumoral liver). Patients with advanced age may have substantial comorbidities that can affect their life expectancy, and tolerance to radiation in elderly patients may be altered. The purpose of this study is to evaluate the safety and survival of elderly patients treated with 90Y-RE.
Side effects of yttrium-90 radioembolization. [2022]Limited therapeutic options are available for hepatic malignancies. Image guided targeted therapies have established their role in management of primary and secondary hepatic malignancies. Radioembolization with yttrium-90 ((90)Y) microspheres is safe and efficacious for treatment of hepatic malignancies. The tumoricidal effect of radioembolization is predominantly due to radioactivity and not ischemia. This article will present a comprehensive review of the side effects that have been associated with radioembolization using (90)Y microspheres. Some of the described side effects are associated with all transarterial procedures. Side effects specific to radioembolization will also be discussed in detail. Methods to decrease the incidence of these potential side effects will also be discussed.
Yttrium-90 Radioembolization: Current Indications and Outcomes. [2023]Radioembolization (RE) with 90Yttrium (Y90) has generally been used to treat patients with advanced disease. Recent data suggest, however, that RE is also safe and feasible to treat patients with early or intermediate stage disease. We herein review the current evidence regarding the use of RE with Y90 for patients with HCC.
Temporary balloon occlusion of the common hepatic artery for administration of yttrium-90 resin microspheres in a patient with patent hepatoenteric collaterals. [2016]The most common serious complication of yttrium-90 ((90)Y) therapy is gastrointestinal ulceration caused by extrahepatic microsphere dispersion. The authors describe the use of a balloon catheter for temporary occlusion of the common hepatic artery to reverse hepatoenteric flow for lobar administration of resin microspheres when coil embolization of a retroportal artery was impossible. At 9 months after treatment, the patient had no gastrointestinal side effects and showed a partial response.
Optimization of radioembolic effect with extended-shelf-life yttrium-90 microspheres: results from a pilot study. [2009]To evaluate the safety and efficacy of yttrium-90 ((90)Y) radioembolization with extended-shelf-life glass microspheres. We postulated that this approach, for the same planned tissue dose of 120 Gy, would increase the embolic load, improve distribution, and result in enhanced tumor response without causing additional adverse events.
Yttrium-90 radioembolization of renal cell carcinoma metastatic to the liver. [2012]To investigate the safety and efficacy of yttrium-90 ((90)Y) hepatic radioembolization treatment of patients with liver-dominant metastatic renal cell carcinoma (RCC) refractory to immunotherapy and targeted therapies.
The effect of catheter-directed CT angiography on yttrium-90 radioembolization treatment of hepatocellular carcinoma. [2005]Yttrium 90 radioembolization is a transcatheter therapy for unresectable hepatocellular carcinoma (HCC) that delivers internal radiation to tumors. In contrast to the usual method of lobar regional delivery, catheter-directed computed tomographic (CT) angiography was investigated as a potentially useful technique to evaluate the administration of segmental 90Y tumor radiation doses superselectively without significantly altering liver function or Child-Pugh classification.
Y90-radioembolization of lung metastases via the bronchial artery: a report of 2 cases. [2017]We report successful Y90-radioembolization of the lung applying Y90-resin microspheres via the bronchial artery in two patients with diffuse colorectal and renal cancer metastases, respectively. The deposition of radioactive Y90-resin-microspheres was technically feasible and resulted in a reasonable absorbed dose in the tumors. However, open questions remain regarding dosimetry and safe dose exposure to the lung. The technique warrants thorough investigation before clinical use. A Phase I trial to evaluate safety and preliminary efficacy is under preparation.
Radioembolisation using yttrium 90 (Y-90) in patients affected by unresectable hepatic metastases. [2021]This study was done to evaluate the effectiveness of radioembolisation of liver metastases with yttrium 90 (Y-90) in patients with no response to chemotherapy.