Testing Y-90 Selective Internal Radiation for renal cell carcinoma (RCC)
Official title: Ablative Radioembolization of Renal Cell Carcinoma Trial
Ablative Yttrium-90 Radioembolization Therapy for Non-Metastatic Renal Cell Carcinoma (ARRCC Trial)
- Phase 2
- 1 group
- One site, in London
- Recruiting
Interventions
- Medical device
Y-90 Selective Internal Radiation Therapy (SIRT)
Y-90 radioembolization will be performed using glass spheres to treat non-metastatic RCC within the kidney.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
London Health Sciences Centre - Victoria Hospital
London, Ontario
Eligibility Criteria
See who this study is looking for34 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Patients willing to participate and provide written consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +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 careStandard of careThe treatment normally given for a condition outside a study.Read more → 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 )
- +Sexually active male subjects must use a condom during intercourse while receiving treatment and for at least 120 days after the last dose of the study treatment and should not father a child during this period.
- +Vasectomized men are also required to use a condom during intercourse, including with a male partner, to prevent delivery of the drug via seminal fluid.
- +For women of childbearing potential (WOCBP):
- +Negative serum pregnancy test within 48 hours prior to the first dose of study treatment
- +Agreement to use barrier contraception and a second form of highly effective contraception (Clinical Trials Facilitation Group \[CTFG\] 2020) while receiving study treatment and for 7 months following their last dose of study treatment. Alternatively, total abstinence is also considered a highly effective contraception method when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- +Male study subjects whose sexual partners are WOCBP must also agree to use a second form of highly effective contraception (CTFG 2020) while receiving 90Y and for at least 4 months following their last dose. Alternatively, total abstinence is also considered a highly effective contraception method when this is in line with the preferred and usual lifestyle of the subject.
Exclusion
- −History of severe allergy to CT contrast medium or any study product ingredients that cannot be managed medically
- −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
- −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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'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 chronic lung disease with baselineBaselineYour starting measurements, taken before treatment begins.Read more → 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 eventAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → 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 \> 1 year
- −Pregnant or breast-feeding patient
- −RCC that is locally recurrent at prior surgery or ablation siteTrial siteA hospital or clinic where a study is actually run.Read more → (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.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study is in one group and receives Y-90 Selective Internal Radiation Therapy (SIRT).
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 16 people.
The study is currently expected to finish around December 2032.
The main measurement is taken over: From treatment until 12 months follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → imaging.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Oncologic tumor response at 12 months — measured over From treatment until 12 months follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → imaging.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06642220 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About 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.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From treatment until 12 months follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → imaging.
The study as a whole is currently expected to finish around 2032-12-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 16 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: London, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.