Ablative Radioembolization of Renal Cell Carcinoma Trial

NCT06642220 | Recruiting Phase 2 DMC

• 1 other identifier: ARRCC 2025-1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Renal Cell Carcinoma (RCC); Radioembolization

Keywords

renal cell carcinoma; radioembolization; selective internal radiation therapy (SIRT); Y-90; Transarterial radioembolization (TARE); RCC

Outcome Measures

Primary Outcomes (1)

• Oncologic tumor response at 12 months

  Assessment the cancer treatment response within the 12 months after treatment. Oncologic response will be based on the modified RECIST (mRECIST) criteria.

  From treatment until 12 months follow-up imaging

Secondary Outcomes (13)

• Treatment-related Adverse Events

  Evaluated from Y-90 therapy until 30 days, 1 year & 5 year follow-up

• Safety and tolerability of ablative doses (400-600 Gy) of Y-90 spheres administered in the kidney

  Evaluated from Y-90 therapy until 30 days, 1 year & 5 year follow-up

• Impact on global renal function

  Will be evaluated at the time of Y-90 therapy as well as after Y-90 therapy at 3 months (10-16 weeks), 6 months (24-30 weeks), 12 months (50-56 weeks), & 2-, 3-, 4-, 5-years time points

• Patient-reported outcomes

  Collected at enrollment and then at 7-days, 14-days, 30-days & 3 months after Y-90 therapy.

• Change in Split Renal Function

  Will be calculated at the time of Y-90 therapy (baseline) as well as after Y-90 therapy at 3 months (10-16 weeks), 6 months (24-30 weeks), 12 months (50-56 weeks), & 2-, 3-, 4-, 5-years

Study Arms (1)

Y-90 radioembolization treatment arm

EXPERIMENTAL

Patients with non-metastatic renal cell carcinoma (RCC) that is \> 4 cm without local invasion (i.e. T1b or T2) who are poor candidates for surgery will have their tumors treated with transarterial radioembolization with Y-90 glass spheres.

Device: Y-90 Selective Internal Radiation Therapy (SIRT)

Interventions

Y-90 Selective Internal Radiation Therapy (SIRT) DEVICE

Y-90 radioembolization will be performed using glass spheres to treat non-metastatic RCC within the kidney.

Y-90 radioembolization treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients willing to participate and provide written consent
• Patients 18 years of age and older
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2
• Biopsy confirmed RCC \> 4.0 cm and no renal vein or IVC involvement (T1b or T2 disease)
• Not suitable for or declining standard of care nephrectomy or partial nephrectomy
• Adequate hepatic function, defined by the following laboratory results:
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN) (or ≤5 × ULN if presence of liver metastases)
• Total bilirubin ≤3 × ULN
• Serum albumin ≥3.0 g/dL unless prothrombin time (PT) is within the normal range
• Adequate hematologic function, defined by the following laboratory results:
• Hemoglobin concentration ≥8.0 g/dL
• Absolute neutrophil count (ANC) ≥1000 cells/µL (≥1000 cells/mm3 )
• Platelets \>50 × 109 /L (100 × 103 /mm3 )
• For women of childbearing potential (WOCBP):
• Negative serum pregnancy test within 48 hours prior to the first dose of study treatment

You may not qualify if:

• Evidence of metastatic disease on CT or MRI
• Severely impaired renal function (GFR ≤ 30 mL/min/1.73m²) and not on dialysis
• Bilateral RCC without plan for definitive therapy of the contralateral lesion
• RCC that is locally recurrent at prior surgery or ablation site (new location in same or contralateral kidney is permitted)
• Prior or concurrent kidney radiation therapy or systemic immunotherapy/TKI
• Lung shunt with estimated lung radiation dose \> 30 Gy for single dose or \> 50 Gy total.
• Planning angiogram cone beam CT from all accessible feeding arteries shows lack of perfusion to all or portions of the RCC tumour such that, in the investigator's opinion, Y-90 radioembolization would result in substantial RCC tumour being untreated or receive an inadequate dose.
• Contraindication to arterial renal angiogram, or both CT and MRI contrast medium
• History of severe allergy to CT contrast medium or any study product ingredients that cannot be managed medically
• History of chronic lung disease with baseline oxygen saturation \< 90% or requiring home oxygen therapy.
• Congestive heart failure with ejection fraction \< 40%
• Presence of active infection, defined by the investigator as clinically significant.
• Any chronic condition that is severe or unstable and, in the opinion of the investigator, would put the patient at unacceptable risk of adverse event related to the Y-90 radioembolization procedure. Such conditions include but are not limited to: unstable angina, congestive heart failure, interstitial lung disease, severe gastrointestinal disease with diarrhea.
• Life expectancy \&gt; 1 year
• Pregnant or breast-feeding patient

Sponsors & Collaborators

• Derek W. Cool: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

London Health Sciences Centre - Victoria Hospital

London, Ontario, N6A 5W9, Canada

RECRUITING

Related Publications (12)

• Summerlin AL, Lockhart ME, Strang AM, Kolettis PN, Fineberg NS, Smith JK. Determination of split renal function by 3D reconstruction of CT angiograms: a comparison with gamma camera renography. AJR Am J Roentgenol. 2008 Nov;191(5):1552-8. doi: 10.2214/AJR.07.4023.

  PMID: 18941100 BACKGROUND

• Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.

  PMID: 20685078 BACKGROUND

• Lencioni R, Llovet JM. Modified RECIST (mRECIST) assessment for hepatocellular carcinoma. Semin Liver Dis. 2010 Feb;30(1):52-60. doi: 10.1055/s-0030-1247132. Epub 2010 Feb 19.

  PMID: 20175033 BACKGROUND

• MacKie S, de Silva S, Aslan P, Ladd L, Houang M, Cade D, Delprado W. Super selective radio embolization of the porcine kidney with 90yttrium resin microspheres: a feasibility, safety and dose ranging study. J Urol. 2011 Jan;185(1):285-90. doi: 10.1016/j.juro.2010.09.001.

  PMID: 21075399 BACKGROUND

• de Silva S, Mackie S, Aslan P, Cade D, Delprado W. Histological Comparison of Kidney Tissue Following Radioembolization with Yttrium-90 Resin Microspheres and Embolization with Bland Microspheres. Cardiovasc Intervent Radiol. 2016 Dec;39(12):1743-1749. doi: 10.1007/s00270-016-1482-3. Epub 2016 Oct 14.

  PMID: 27743088 BACKGROUND

• Reig M, Forner A, Rimola J, Ferrer-Fabrega J, Burrel M, Garcia-Criado A, Kelley RK, Galle PR, Mazzaferro V, Salem R, Sangro B, Singal AG, Vogel A, Fuster J, Ayuso C, Bruix J. BCLC strategy for prognosis prediction and treatment recommendation: The 2022 update. J Hepatol. 2022 Mar;76(3):681-693. doi: 10.1016/j.jhep.2021.11.018. Epub 2021 Nov 19.

  PMID: 34801630 BACKGROUND

• Tong AK, Kao YH, Too CW, Chin KF, Ng DC, Chow PK. Yttrium-90 hepatic radioembolization: clinical review and current techniques in interventional radiology and personalized dosimetry. Br J Radiol. 2016 Jun;89(1062):20150943. doi: 10.1259/bjr.20150943. Epub 2016 Mar 24.

  PMID: 26943239 BACKGROUND

• Gabr A, Kulik L, Mouli S, Riaz A, Ali R, Desai K, Mora RA, Ganger D, Maddur H, Flamm S, Boike J, Moore C, Thornburg B, Alasadi A, Baker T, Borja-Cacho D, Katariya N, Ladner DP, Caicedo JC, Lewandowski RJ, Salem R. Liver Transplantation Following Yttrium-90 Radioembolization: 15-Year Experience in 207-Patient Cohort. Hepatology. 2021 Mar;73(3):998-1010. doi: 10.1002/hep.31318. Epub 2020 Nov 7.

  PMID: 32416631 BACKGROUND

• Kluetz PG, Slagle A, Papadopoulos EJ, Johnson LL, Donoghue M, Kwitkowski VE, Chen WH, Sridhara R, Farrell AT, Keegan P, Kim G, Pazdur R. Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms. Clin Cancer Res. 2016 Apr 1;22(7):1553-8. doi: 10.1158/1078-0432.CCR-15-2035. Epub 2016 Jan 12.

  PMID: 26758559 BACKGROUND

• McGregor H, Laidlaw G, Johnson G. Ablative Radioembolization of a Synchronous Renal Cell Carcinoma and Hepatocellular Carcinoma. J Vasc Interv Radiol. 2023 Oct;34(10):1847-1849. doi: 10.1016/j.jvir.2023.06.028. Epub 2023 Jun 28. No abstract available.

  PMID: 37391075 BACKGROUND

• Hamoui N, Gates VL, Gonzalez J, Lewandowski RJ, Salem R. Radioembolization of renal cell carcinoma using yttrium-90 microspheres. J Vasc Interv Radiol. 2013 Feb;24(2):298-300. doi: 10.1016/j.jvir.2012.10.027. Epub 2013 Jan 28. No abstract available.

  PMID: 23369565 BACKGROUND

• de Souza PL, Aslan P, Clark W, Nour R, de Silva S. RESIRT: A Phase 1 Study of Selective Internal Radiation Therapy Using Yttrium-90 Resin Microspheres in Patients With Primary Renal Cell Carcinoma. Clin Genitourin Cancer. 2022 Oct;20(5):442-451. doi: 10.1016/j.clgc.2022.05.006. Epub 2022 May 18.

  PMID: 35710899 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Sarah DeBrabandere, PhD

CONTACT

5196858500; sarah.debrabandere@lhsc.on.ca

Craig Johnson, PhD

CONTACT

craig.johnson@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 6, 2024
• First Posted: October 15, 2024
• Study Start: July 9, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 31, 2032
• Last Updated: July 20, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 3 months after publication and ending 48 months after article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

CA (1)