Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06432036

Yttrium-90 (Y90) Radioembolization for the Treatment of Early Stage Renal Cell Carcinoma, The RENEGADE Trial

Led by Jonsson Comprehensive Cancer Center · Updated on 2026-03-06

25

Participants Needed

1

Research Sites

126 weeks

Total Duration

On this page

Sponsors

J

Jonsson Comprehensive Cancer Center

Lead Sponsor

B

Boston Scientific Corporation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Yttrium-90 (Y90) Radioembolization for the Treatment of Early Stage Renal Cell Carcinoma, The RENEGADE Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be aged 2 18 years or older at screening
  • Signed informed consent obtained before any study procedures
  • Life expectancy of at least 12 months
  • Diagnosis of renal cell carcinoma by imaging and histology
  • Clinical stage T1 or T2a, N0M0
  • 1 to 2 solid target lesions (>80% solid)
  • Not suitable for partial nephrectomy or thermal ablation based on tumor board decision
  • Not candidates for long-term active surveillance due to tumor growth or size
  • Not ideal candidates for radical nephrectomy due to surgical risk or health concerns
  • Measurable tumor according to RECIST 1.1 criteria
  • No bilateral renal tumors
  • Negative pregnancy test for females of childbearing potential; breastfeeding females excluded
  • Hemoglobin 2 9.0 g/dL or higher
  • Absolute neutrophil count 2 1.5 x 10^9/L or higher
  • Absolute lymphocyte count 2 1.0 x 10^9/L or higher
  • Platelet count 2 75 x 10^9/L or higher
  • Glomerular filtration rate (GFR) 2 45 mL/min/1.73 m^2 or higher
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Successful tumor localization by screening angiogram allowing Y-90 delivery without venous shunting
Not Eligible

You will not qualify if you...

  • Any contraindication to angiography or selective renal artery catheterization
  • Arterial flow to gastrointestinal tract uncorrectable by angiographic techniques
  • Poor tumor targeting on angiography that prevents adequate dosing
  • Excessive non-tumoral kidney tissue exposure decreasing GFR below 45 mL/min/1.73 m^2
  • Renal venous shunting visible on angiography
  • Metastases outside kidney including enlarged abdominal lymph nodes or lung nodules
  • Brain metastases, leptomeningeal carcinomatosis, or spinal cord compression
  • Tumor invasion into renal vein, artery, or collecting system
  • Prior abdominal radiation therapy including to index tumor
  • Concurrent RCC treatment or recent treatment within 6 months unless observational or prior randomization
  • History of active immunodeficiency
  • Presence of renal ureteral stent in treatment kidney
  • History of other malignancies within 3 years except select low-risk cancers
  • Major surgery within 28 days before enrollment
  • Severe allergy or intolerance to contrast agents, narcotics, sedatives, or atropine
  • Active infection
  • Pregnant or breastfeeding females, or females unwilling to use birth control
  • Unstable chronic diseases or conditions increasing risk or limiting study compliance
  • Pulmonary insufficiency with oxygen saturation below 90%
  • Solitary kidney
  • Inability to comply with study requirements or protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States, 90095

Actively Recruiting

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Research Team

A

Amelia Ferrer

CONTACT

S

Saima Chaabane

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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