Y-90 Radioembolization for Kidney Cancer

Overseen By Amelia Ferrer

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Metastases, Prior radiation, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment for early-stage kidney cancer called Y-90 radioembolization. Y-90, a radioactive substance, is injected in tiny glass spheres directly into the artery feeding the cancer. The trial aims to determine its safety, potential side effects, and effectiveness. It suits those diagnosed with early-stage renal cell carcinoma who cannot undergo surgery or other local treatments. Participants should have solid tumors and be unsuitable for radical surgery due to health risks. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative treatment.

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 there any evidence suggesting that Y-90 radioembolization is likely to be safe for humans?

Research has shown that Yttrium-90 (Y90) radioembolization treats liver cancers effectively and safely. In studies with liver cancer patients, this treatment controlled the disease and extended patients' lives, indicating it is generally well-tolerated.

While Y90 radioembolization has approval in some areas for liver cancer, it is not yet approved for kidney cancer. However, previous studies have not reported serious side effects, which is encouraging. As this treatment is in the early stages of testing for kidney cancer, researchers continue to assess its safety for this specific use. Early trials primarily focus on ensuring safety, so further testing of Y90 suggests it has shown enough promise in initial studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for kidney cancer, which often include surgery, targeted therapy, and immunotherapy, Yttrium-90 (Y90) radioembolization offers a unique approach by delivering radiation directly to the tumor. This method involves using tiny beads filled with the radioactive isotope Yttrium-90, which are injected into the blood vessels feeding the tumor, targeting the cancer cells while sparing surrounding healthy tissue. Researchers are excited about this treatment because it provides a highly localized form of radiation therapy, potentially leading to fewer side effects and improved outcomes for patients who may not be surgical candidates.

What evidence suggests that Y-90 radioembolization might be an effective treatment for kidney cancer?

Research shows that Yttrium-90 (Y-90) radioembolization, which participants in this trial will receive, is a promising treatment for certain cancers. Studies have found it safe and effective for managing liver-dominant metastatic renal cell carcinoma, a type of kidney cancer. This treatment targets and destroys cancer cells by injecting tiny radioactive beads into the artery that feeds the tumor. Evidence from past studies suggests this method can help control the disease and improve survival rates. While primarily used for liver cancers, early findings indicate it might also benefit early-stage kidney cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

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.

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.

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?

Group I: Treatment (radioembolization, TheraSphere) Experimental Treatment 7 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.

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

Boston Scientific Corporation

Chief Executive Officer since 2016

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

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

CT angiography allows for more precise targeting of Yttrium 90 (90Y) radioembolization in patients with unresectable hepatocellular carcinoma (HCC), significantly increasing the effective radiation dose to tumors from a mean of 100 Gy to 348 Gy (P < .001).

This method does not adversely affect liver function, as evidenced by minimal changes in serum bilirubin levels and no significant alterations in Child-Pugh classification in 13 out of 14 patients, indicating its safety for use in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of catheter-directed CT angiography on yttrium-90 radioembolization treatment of hepatocellular carcinoma. Rhee, TK., Omary, RA., Gates, V., et al.[2005]

Y90-radioembolization using Y90-resin microspheres delivered via the bronchial artery was successfully performed in two patients with metastatic colorectal and renal cancers, indicating the technique's feasibility.

While the procedure resulted in a reasonable absorbed dose to the tumors, further research is needed to address safety concerns and dosimetry before it can be widely used in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Y90-radioembolization of lung metastases via the bronchial artery: a report of 2 cases. Ricke, J., Großer, O., Amthauer, H.[2017]

Yttrium-90 (Y-90) radioembolisation demonstrated a good response rate in treating liver metastases in 110 patients who did not respond to chemotherapy, with 45 patients showing a complete or partial response and 90 patients experiencing a decrease in tumor marker levels.

The treatment had a high technical success rate of 96% and an estimated effectiveness of 83.6% at 3 months, with manageable side effects, indicating that Y-90 radioembolisation is a feasible and safe option for patients with liver metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radioembolisation using yttrium 90 (Y-90) in patients affected by unresectable hepatic metastases. Cianni, R., Urigo, C., Notarianni, E., et al.[2021]

Yttrium-90 (90Y) hepatic radioembolization showed promising efficacy in treating liver-dominant metastatic renal cell carcinoma (RCC) in six patients who were resistant to previous therapies, with three achieving complete responses and one a partial response over a follow-up period of up to 64 months.

The treatment was generally safe, with only mild toxicities (grades 1 and 2) reported, primarily fatigue, indicating that 90Y radioembolization could be a viable option for patients with limited treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yttrium-90 radioembolization of renal cell carcinoma metastatic to the liver. Abdelmaksoud, MH., Louie, JD., Hwang, GL., et al.[2012]

Radioembolization with yttrium-90 microspheres is a safe and effective treatment for hepatic malignancies, primarily due to its tumor-killing radioactivity rather than causing ischemia.

The article reviews various side effects associated with radioembolization, including those common to all transarterial procedures, and discusses strategies to minimize these side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side effects of yttrium-90 radioembolization. Riaz, A., Awais, R., Salem, R.[2022]

The use of a balloon catheter to temporarily occlude the common hepatic artery can effectively reverse hepatoenteric flow, allowing for safer lobar administration of yttrium-90 microspheres when other methods are not feasible.

In a case study, this technique resulted in no gastrointestinal side effects and a partial response in the patient after 9 months, highlighting its potential efficacy and safety in managing complications associated with (90)Y therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporary balloon occlusion of the common hepatic artery for administration of yttrium-90 resin microspheres in a patient with patent hepatoenteric collaterals. Mahvash, A., Zaer, N., Shaw, C., et al.[2016]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Radioembolization (RE) with 90Yttrium (Y90) is safe and effective for treating patients with early and intermediate-stage hepatocellular carcinoma (HCC), showing comparable survival and disease progression outcomes to standard treatments.

Y90 RE can also serve as a downstaging treatment for advanced HCC, helping patients who initially do not meet liver transplant criteria by promoting liver regeneration while targeting tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yttrium-90 Radioembolization: Current Indications and Outcomes. Hamad, A., Aziz, H., Kamel, IR., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Yttrium-90 microsphere radioembolization shows promise as a treatment for lung cancer that has spread to the liver, with effective results observed in two case studies.

This therapy could potentially improve outcomes for patients with advanced-stage lung cancer and liver-dominant metastases, suggesting a new avenue for treatment in a disease with poor survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yttrium-90 microsphere radioembolization for treatment of lung cancer hepatic metastases. Gaba, RC., Lakhoo, J.[2022]

In a study of 255 patients treated with Yttrium 90 microsphere radioembolization for liver cancer, elderly patients (aged ≥ 70 years) experienced similar complication rates to younger patients, indicating that age alone does not increase the risk of treatment-related toxicity.

The median overall survival rates for elderly and younger patients with hepatocellular carcinoma were comparable, suggesting that elderly patients can safely undergo 90Y-RE without compromising their survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liver radioembolization using 90Y resin microspheres in elderly patients: tolerance and outcome. Iñarrairaegui, M., Bilbao, JI., Rodríguez, M., et al.[2018]

In a study of 50 patients with liver tumors, yttrium-90 radioembolization using extended-shelf-life glass microspheres delivered a mean radiation dose of 126 Gy, resulting in a significant increase in embolic load by 111%, which improved tumor response rates.

The treatment demonstrated a safety profile with manageable side effects, including fatigue and abdominal pain, and achieved response rates of 51% and 69% according to WHO and EASL guidelines, respectively, indicating its efficacy in treating liver tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimization of radioembolic effect with extended-shelf-life yttrium-90 microspheres: results from a pilot study. Lewandowski, RJ., Riaz, A., Ryu, RK., et al.[2009]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7771309/

Transarterial Yttrium-90 Radioembolization Treatment of ... Radioembolization is safe and effective and led to improved hepatic disease control and overall survival in patients with liver-dominant metastatic RCC.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06432036

Yttrium-90 (Y90) Radioembolization for the Treatment of ... This process is called radioembolization. Y-90 radioembolization may be a safe and effective treatment for patients with early stage renal cell carcinoma.

3. jvir.org jvir.org/article/S1051-0443(24)00454-8/fulltext

Outcomes Analysis of Yttrium-90 Radioembolization for ... To characterize the response and survival outcomes of yttrium-90 ( 90 Y) transarterial radioembolization (TARE) for unresectable, liver-dominant metastases.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1051044311014515

Yttrium-90 Radioembolization of Renal Cell Carcinoma ... Purpose. To investigate the safety and efficacy of yttrium-90 (90Y) hepatic radioembolization treatment of patients with liver-dominant ...

5. bostonscientific.com bostonscientific.com/en-US/medical-specialties/interventional-radiology/interventional-oncology/therasphere/clinical-data/1000-patient-study.html

1000 Patient Study TheraSphere™ Treatment Results Review clinical research on TheraSphere™ Y-90 for liver cancer. Learn how this radioembolization study highlights treatment outcomes and patient efficacy.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06642220

Ablative Radioembolization of Renal Cell Carcinoma Trial Existing Safety Data of Y-90 in the kidney: Health Canada approval of Y-90 radioembolization is currently only for treatment of malignancies in the liver ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1051044316305620

Transarterial Yttrium-90 Radioembolization Treatment of ... To evaluate safety and efficacy of transarterial hepatic radioembolization treatment of patients with liver-dominant metastatic renal cell carcinoma (RCC).