Yttrium-90 Radioembolization for Early Stage Kidney Cancer (RENEGADE Trial)
This study, called the RENEGADE Trial, is testing a treatment called yttrium-90 (Y-90) radioembolization for people with early stage kidney cancer (renal cell carcinoma). Y-90 radioembolization involves injecting tiny glass spheres containing a radioactive chemical directly into the artery that feeds the cancer. Researchers want to see how safe and effective this treatment is. They will be looking at side effects and how well the treatment shrinks the tumor. You may be able to join if you are 18 or older, have early stage kidney cancer, and a life expectancy of at least 12 months. The study is currently unclear on its recruitment status and plans to enroll 25 participants.
- Study design
- This is an interventional study with an unclear phase, planning to enroll 25 participants. It is testing the safety and effectiveness of Yttrium-90 radioembolization.
- What's involved
- You would undergo an angiogram, blood sample collection, CT scans, SPECT scans, and the radioembolization procedure. You will have follow-up visits for up to 24 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants are followed up at 1 day, 1 week, and then monthly for 24 months after treatment.
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NCT06432036
Yttrium-90 (Y90) Radioembolization for the Treatment of Early Stage Renal Cell Carcinoma, The RENEGADE Trial
Recruiting
PHASE1Ages 18+InterventionalTreatmentJonsson Comprehensive Cancer CenterInvestigator-initiated
~25 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:AngiogramBiospecimen CollectionComputed TomographyRadioembolizationSingle Photon Emission Computed TomographySurvey Administration
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of treatment related adverse events
Measured over Up to 2 years
+1 more outcome measured
Conditions
Where it's being run
2 sites across 2 statesCalifornia1
Colorado1
Study leadership
- Siddharth A Padia · PRINCIPAL_INVESTIGATOR · UCLA / Jonsson Comprehensive Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participants must be aged ≥ 18 years at the time of screening
Written informed consent and any locally required authorization (e.g., Health Insurance Portability and accountability Act) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations
Life expectancy ≥ 12 months
RCC, diagnosed by radiographic imaging and histology
Clinical stage of RCC: T1 or T2a, Cancer stage (N0M0)
1-2 solid (\> 80% solid) target lesions
Patient not an ideal candidate for partial nephrectomy or thermal ablation at the time of study entry, based on the decision of the institution's multidisciplinary tumor board. Contraindications for partial nephrectomy include inability to potentially partially resect the kidney, high risk of adverse events due to medical comorbidities, or potential high risk of adverse events due to general anesthesia. Contraindications to thermal ablation include potential inability to technically place ablation probes into the tumor, central tumors which risk thermal injury to the renal collecting system
Patient not considered a candidate for long-term active surveillance due to oncologic risk due to tumor growth and/or tumor size
Patient not considered ideal candidates for radical nephrectomy due to surgical comorbidity and/or development of adverse health outcomes
Measurable tumor by RECIST 1.1 criteria
Absence of bilateral renal tumors
Negative serum pregnancy test in females of child-bearing potential; patients who are breast-feeding cannot participate in this trial
Hemoglobin ≥ 9.0 g/dL
Absolute neutrophil count ≥ 1.5 x 10\^9/L
Absolute lymphocyte count ≥ 1.0 x 10\^9/L
Platelet count ≥ 75 x 10\^9/L
Glomerular filtration rate (GFR) ≥ 45 mL/min/1.73 m\^2
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
Screening mapping angiogram demonstrates successful localization of tumor(s), where catheter placement location(s) would allow Y90 to distribute in the intended treatment area, without venous shunting
Exclusion
Any contraindication to angiography or selective renal artery catheterization
Screening angiography with cone beam CT (CBCT) shows any arterial flow to the gastrointestinal tract uncorrectable by angiographic techniques
Screening angiography with CBCT shows poor tumor targeting that would lead to a dose that does not meet the renal dosing criteria. This typically occurs when a feeding artery to the tumor cannot be identified
Screening angiography demonstrates excessive non-tumoral renal parenchyma will be in the treatment field, that the new baseline glomerular filtration rate will be \< 45 mL/min/1.73 m\^2
Screening angiography demonstrates renal venous shunting of iodinated contrast that is immediately visible upon arterial injection
Extra-renal metastases, including patients with abdominal lymph nodes \>1.5 cm in shorter axis, or with lung nodules (single lesion, \>1 cm, or multiple smaller lesions with a total diameter \>2 cm)
Brain metastases, leptomeningeal carcinomatosis or spinal cord compression. Patients with suspected brain metastases at screening should have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry
Evidence of any tumor invasion into the renal vein, renal artery, or renal collecting system
Any prior radiation therapy to the abdomen, including localized radiation therapy to the index tumor
Concurrent treatment for RCC or treatment in the last 6 months in another clinical study, unless it is an observational study (non-interventional) or during a non-interventional follow-up stage of an interventional study, or prior randomization to this study
History of active primary/acquired immunodeficiency
Presence of renal ureteral stent in the treatment kidney at any time
History of malignancy, other than RCC, within three years, with the exception of adequately treatment carcinoma in situ of the cervix, early squamous cell carcinoma or basal cell carcinoma of the skin, localized prostate cancer, ductal carcinoma in situ, or low-grade endometrial carcinoma with no myometrial invasion (negligible risk of metastases or death 5-year overall survival \[OS\] rate \> 90%)
Major surgical procedure (as defined by the Investigator) within 28 days prior to enrollment
A history of severe allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically
Active infection
Female patients who are pregnant or breastfeeding or female patients of reproductive potential who are not willing to employ effective birth control from screening to 6 months after treatment
Unstable chronic disease or evidence of any disease or condition that would place the patient at undue risk and preclude safe use of Y90 microspheres, including but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the patient to give written informed consent
History of pulmonary insufficiency, measured by oxygen saturation of less than 90%
Solitary kidney
Patient not able to follow the study protocol requirements
What this trial measures
- Number of treatment related adverse eventsUp to 2 years
- Number of serious adverse eventsUp to 2 years