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Stage I Renal Cell CancerPhase 1/2NCT06432036

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

A Phase 1/2 study testing Angiogram, Biospecimen Collection and Computed Tomography in people with Stage I Renal Cell Cancer and Stage II Renal Cell Cancer, run by Jonsson Comprehensive Cancer Center at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Angiogram, Biospecimen Collection and Computed Tomography
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
2 sitesUnited States
Study dates
26 Dec 2024to Mar 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 19Show fewer
  • 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

Who cannot join

  • 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)
Show all 21Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Aniket U. Joglekar contact

310-948-8026

ajoglekar@mednet.ucla.edu

Saima Chaabane contact

(310)794-8995

schaabane@mednet.ucla.edu

United States2 sites, 2 recruiting

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

    Shireen Shikak, (303) 724-5000, Shireen.shikak@cuanschutz.edu

    Leigh Casadaban, MD

    Recruiting

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

    Aniket U. Joglekar, (310) 948-8026, ajoglekar@mednet.ucla.edu

    Saima Chaabane, (310)794-8995, schaabane@mednet.ucla.edu

    Recruiting

Other trials in United States

About this study

Official title: RENEGADE: Radioembolization for Early Stage Renal Cell Carcinoma: An Open-Label, Prospective, Multi-Center, Phase 1/2 Safety Trial

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To assess safety and toxicity of Yttrium-90 radioembolization for renal cell carcinoma (RCC).

SECONDARY OBJECTIVES:

  1. To assess tumor response and duration of response, based on Choi, Response Evaluation Criteria in Solid Tumors (RECIST), and modified RECIST criteria.

II. To assess time to disease progression. III. To assess progression free survival and overall survival. IV. To assess stability of renal function via glomerular filtration rate (GFR) and cystatin-C.

  1. To describe the difference in quality of life before and after treatment using Eastern Cooperative Oncology Group (ECOG) performance status and RCC-specific Quality of Life (QoL) questionnaire.

OUTLINE:

Patients undergo radioembolization with yttrium Y 90 glass microspheres (TheraSphere) given intra-arterially. Patients undergo angiogram during screening, single proton emission computed tomography (SPECT) scan on study and computed tomography (CT) scan and blood sample collection throughout the study.

After completion of study treatment, patients are followed up at 1 day, 1 week, and then monthly for 24 months.

Being tested
Angiogram, Biospecimen Collection, Computed Tomography, Radioembolization, Single Photon Emission Computed Tomography
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AngiogramProcedure or surgery

    Undergo angiogram

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scan

  • RadioembolizationRadiation

    Also called intra-arterial brachytherapy

    Undergo radioembolization

  • Single Photon Emission Computed TomographyProcedure or surgery

    Also called Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, Single-Photon Emission Computed, single-photon emission computed tomography

    Undergo SPECT

  • Survey AdministrationOther

    Ancillary study

  • Yttrium Y 90 Glass MicrospheresRadiation

    Also called TheraSphere, Y-90 Therasphere

    Given intra-arterially

Study groups in NCT06432036
Study groupRoleWhat they receive
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.
Receives: Procedure: Angiogram; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Radiation: Radioembolization; Procedure: Single Photon Emission Computed Tomography; Other: Survey Administration; Radiation: Yttrium Y 90 Glass Microspheres

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of treatment related adverse events

    Measured: Up to 2 years

  2. Number of serious adverse events

    Measured: Up to 2 years

Secondary outcomes (15)

  1. Overall response rate (ORR)

    According to Choi, Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, and modified RECIST. Will be summarized as count and percentage. The corresponding 95% confidence interval (CI) for the ORR will be computed using the methodology of Clopper-Pearson.

    Measured: Up to 2 years

  2. Duration of response

    According to Choi, RECIST 1.1, and modified RECIST. Will be analyzed by Kaplan Meier methodology.

    Measured: From the first response and first observation of progressive disease, up to 2 years

  3. Renal time to progression

    According to Choi, RECIST 1.1, and modified RECIST. Kaplan Meier curves will be presented.

    Measured: Up to 2 years

  4. Progression free-survival

    According to Choi, RECIST 1.1, and modified RECIST. Kaplan Meier curves will be presented.

    Measured: Up to 2 years

  5. Overall survival

    Kaplan Meier curves will be presented.

    Measured: Up to 2 years

  6. Change in renal function

    Measured by glomerular filtration rate (GFR), creatinine, and cystatin-C.

    Measured: Up to 2 years

  7. Proportion of patients receiving subsequent treatment for RCC after study treatment

    Will be summarized as counts and percentage. The corresponding 95% CIs will be computed using Clopper-Pearson.

    Measured: Up to 2 years

  8. Type of subsequent RCC treatment received after study treatment

    Will be summarized using descriptive summaries.

    Measured: Up to 2 years

  9. Proportion of patients to undergo curative therapy

    Will be summarized as counts and percentage. The corresponding 95% CIs will be computed using Clopper-Pearson.

    Measured: Up to 2 years

  10. Time to subsequent RCC treatment (local or systemic therapy)

    Will be summarized using descriptive summaries.

    Measured: Up to 2 years

  11. Correlation between tumoral absorbed dose, with efficacy and safety

    Correlation between tumoral absorbed dose (measured in Gy based on SPECT-CT) and safety (measured by incidence of Grade 3/4 treatment-related adverse events) and efficacy (measured by partial and complete response using Choi/mRECIST/RECIST criteria on follow up cross sectional imaging)

    Measured: Up to 2 years

  12. Correlation between normal tissue absorbed dose, with efficacy and safety

    Correlation between normal tissue absorbed dose (measured in Gy based on SPECT-CT) and safety (measured by incidence of Grade 3/4 treatment-related adverse events) and efficacy (measured by partial and complete response using Choi/mRECIST/RECIST criteria on follow up cross sectional imaging)

    Measured: Up to 2 years

  13. Change in Eastern Cooperative Oncology Group score

    The scale is Eastern Cooperative Oncology Group (ECOG). Scale is 1 to 5, with 5 being the worst outcome.

    Measured: Up to 2 years

  14. Change in quality of life as measured by the SF-36 (QualityMetrics) Quality of Life survey

    Change in overall quality of life based on patient-reported outcomes

    Measured: Up to 2 years

  15. Percentage of subjects with absorbed Y90 dose within range (+/- 20%) of planned dose

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2024
  2. Study start26 Dec 2024
  3. Primary completion24 Mar 2029 (estimated)
  4. Study completionMar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06432036
Sponsor's protocol ID
23-001261
Other IDs
NCI-2024-03516
Status last verified
Feb 2026
First submitted
10 May 2024
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • 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.

    PubMed 41276366

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Angiogram, Biospecimen Collection and Computed Tomography in people with Stage I Renal Cell Cancer and Stage II Renal Cell Cancer, run by Jonsson Comprehensive Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aniket U. Joglekar (310-948-8026, ajoglekar@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of treatment related adverse events (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06432036, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

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