Actively Recruiting
Ablative Radioembolization of Renal Cell Carcinoma Trial
Led by Derek W. Cool · Updated on 2025-07-20
16
Participants Needed
1
Research Sites
390 weeks
Total Duration
On this page
Sponsors
D
Derek W. Cool
Lead Sponsor
B
Boston Scientific Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Renal cell carcinoma (RCC), the most common type of kidney cancer, is typically treated with surgery; however, there is no established therapy for patients who are not surgical candidates and who have tumours greater than 4.0 cm in size. Selective internal radiation therapy (SIRT) or radioembolization using radioactive spheres containing 90-Yttrium (Y-90) is successful at treating large tumours with high doses of radiation within the liver and might be similarly effective for treating larger RCC tumours in patients, particularly those who are not surgical candidates. This prospective study will enroll 16 participants with RCC who are not candidates for surgery and treat them with Y-90 radioembolization using a high-dose therapy to see if it is an effective cancer therapy. Primary outcome will be RCC treatment response 1 year after the Y-90 radioembolization. Additionally, the safety, tolerability, and impact on kidney function of the therapy will be monitored for all participants. Patients will be followed for a total of 5 years to evaluate long-term outcome in cancer control and safety of the treatment.
CONDITIONS
Official Title
Ablative Radioembolization of Renal Cell Carcinoma Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients willing to participate and provide written consent
- Patients 18 years of age and older
- Eastern Cooperative Oncology Group (ECOG) performance status 2 or less
- Biopsy confirmed renal cell carcinoma larger than 4.0 cm without renal vein or inferior vena cava involvement (T1b or T2 disease)
- Not suitable for or declining standard nephrectomy or partial nephrectomy surgery
- Adequate liver function with AST and ALT less than or equal to 2.5 times upper limit of normal (or less than or equal to 5 times ULN if liver metastases present)
- Total bilirubin less than or equal to 3 times upper limit of normal
- Serum albumin greater than or equal to 3.0 g/dL unless prothrombin time is normal
- Adequate blood counts with hemoglobin concentration of at least 8.0 g/dL
- Absolute neutrophil count at least 1000 cells/µL
- Platelets greater than 50 x 10^9/L
- For women of childbearing potential: negative pregnancy test within 48 hours before first treatment and agreement to use two forms of contraception or abstinence during treatment and for 7 months after
- Sexually active men must use condoms during treatment and for at least 120 days after last dose and agree to use a second form of contraception if partners are women of childbearing potential
You will not qualify if you...
- Evidence of metastatic disease on CT or MRI scans
- Severely impaired kidney function with glomerular filtration rate 30 mL/min/1.73m² or less and not on dialysis
- Bilateral renal cell carcinoma without a plan for treating the other kidney lesion
- Locally recurrent RCC at prior surgery or ablation site
- Prior or current kidney radiation therapy or systemic immunotherapy or tyrosine kinase inhibitor treatment
- Lung radiation dose estimate greater than 30 Gy for a single dose or 50 Gy total
- Imaging shows poor blood flow to parts of the tumor preventing adequate Y-90 treatment
- Contraindications to kidney artery angiogram or contrast medium used in CT or MRI
- History of severe allergy to CT contrast or study treatment ingredients that cannot be medically managed
- Chronic lung disease with oxygen saturation less than 90% or requiring home oxygen
- Heart failure with ejection fraction less than 40%
- Presence of active infection deemed significant by the investigator
- Any severe or unstable chronic condition considered too risky for Y-90 treatment such as unstable angina, interstitial lung disease, or severe gastrointestinal disease with diarrhea
- Life expectancy less than or equal to 1 year
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
London Health Sciences Centre - Victoria Hospital
London, Ontario, Canada, N6A 5W9
Actively Recruiting
Research Team
S
Sarah DeBrabandere, PhD
CONTACT
C
Craig Johnson, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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