Yttrium-90 (Y90) Radioembolization for the Treatment of Early Stage Renal Cell Carcinoma, The RENEGADE Trial
RENEGADE: Radioembolization for Early Stage Renal Cell Carcinoma: An Open-Label, Prospective, Multi-Center, Phase 1/2 Safety Trial
2 other identifiers
interventional
25
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Dec 2024
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2024
CompletedFirst Posted
Study publicly available on registry
May 29, 2024
CompletedStudy Start
First participant enrolled
December 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
March 6, 2026
February 1, 2026
1.4 years
May 10, 2024
March 4, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Number of treatment related adverse events
Up to 2 years
Number of serious adverse events
Up to 2 years
Secondary Outcomes (15)
Overall response rate (ORR)
Up to 2 years
Duration of response
From the first response and first observation of progressive disease, up to 2 years
Renal time to progression
Up to 2 years
Progression free-survival
Up to 2 years
Overall survival
Up to 2 years
- +10 more secondary outcomes
Study Arms (1)
Treatment (radioembolization, TheraSphere)
EXPERIMENTALPatients 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.
Interventions
Given intra-arterially
Undergo blood sample collection
Undergo CT scan
Undergo radioembolization
Undergo SPECT
Eligibility Criteria
You may qualify if:
- 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)
- 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
- +4 more criteria
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jonsson Comprehensive Cancer Centerlead
- Boston Scientific Corporationcollaborator
Study Sites (1)
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
Related Publications (1)
Meiselman S, Thomas MA, Giardina JD, Zheleznyak A, Thorek DLJ, Malone CD. Advances in Radioembolization for Liver Cancer. J Vasc Interv Radiol. 2025 Dec;36(12):1876-1881. doi: 10.1016/j.jvir.2025.07.018.
PMID: 41276366DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Siddharth A Padia
UCLA / Jonsson Comprehensive Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2024
First Posted
May 29, 2024
Study Start
December 26, 2024
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2027
Last Updated
March 6, 2026
Record last verified: 2026-02