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Y-90 Selective Internal Radiation Therapy

Phase 2

Renal Cell Carcinoma (RCC) | Unknown | Oncology |Boston Scientific Corporation|Last Updated: Jul 20, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

Y-90 Selective Internal Radiation Therapy · 1 trial · 2 indications

Phase 2 1
NCT06642220Ablative Radioembolization of Renal Cell Carcinoma TrialRenal Cell Carcinoma (RCC)
RECRUITING16 Analytics
PHASE2RECRUITING
Ablative Radioembolization of Renal Cell Carcinoma Trial
Renal Cell Carcinoma (RCC)
NCT0664222016
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Study Endpoints

Primary Endpoints

Oncologic tumor response at 12 months
From treatment until 12 months follow-up imaging

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

Secondary Endpoints

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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Y-90 radioembolization treatment armEXPERIMENTALPatients 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.

Interventions

NameTypeDescription
Y-90 Selective Internal Radiation Therapy (SIRT)DEVICEY-90 radioembolization will be performed using glass spheres to treat non-metastatic RCC within the kidney.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 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 f...

Countries:Canada
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Frequently asked questions about Y-90 Selective Internal Radiation Therapy

What is Y-90 Selective Internal Radiation Therapy used for?

Y-90 Selective Internal Radiation Therapy is an investigational treatment being studied for Renal Cell Carcinoma (RCC). It is delivered through a procedure called radioembolization, which is being evaluated in a clinical trial for patients with this type of kidney cancer.

Who is developing Y-90 Selective Internal Radiation Therapy?

Y-90 Selective Internal Radiation Therapy is being developed by Boston Scientific Corporation, a company traded on the New York Stock Exchange under the ticker BSX. The company is sponsoring a clinical trial to evaluate this therapy for Renal Cell Carcinoma.

What phase is Y-90 Selective Internal Radiation Therapy in?

Y-90 Selective Internal Radiation Therapy is currently in Phase 2 clinical development. It is an investigational therapy, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials for Renal Cell Carcinoma.

What clinical trials is Y-90 Selective Internal Radiation Therapy in?

Y-90 Selective Internal Radiation Therapy is being studied in a Phase 2 clinical trial with the identifier NCT06642220, titled 'Ablative Radioembolization of Renal Cell Carcinoma Trial.' The trial is currently recruiting participants in Canada and aims to enroll 16 patients with Renal Cell Carcinoma.

Is Y-90 Selective Internal Radiation Therapy a randomized or blinded trial?

The clinical trial for Y-90 Selective Internal Radiation Therapy is not randomized and is not double-blinded. It is an uncontrolled study, meaning there is no control group receiving a placebo or alternative treatment. All participants receive the investigational therapy.