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Tiny radioactive spheres aim to destroy kidney tumors without surgery

NCT ID NCT06432036

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This study tests the safety and effectiveness of a treatment called radioembolization for people with early stage kidney cancer. Tiny glass spheres containing radioactive yttrium-90 are injected into the artery feeding the tumor to destroy it from inside. The trial will enroll 25 adults with stage I or II kidney cancer to see if this approach is safe and shrinks the cancer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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) * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UCLA / Jonsson Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of Colorado Anschutz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045, United States

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