Tiny radioactive spheres aim to destroy kidney tumors without surgery
NCT ID NCT06432036
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Stage I renal cell cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGLos Angeles, California, 90095, United States
-
University of Colorado Anschutz Medical Campus
RECRUITINGAurora, Colorado, 80045, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A Pre-Surgery Tune-Up: could it help older adults recover faster?
- Radioactive antibody hunt: could a new scan outsmart hidden kidney cancer?
- Can a special MRI spot kidney cancer better?
- Radiation implants take aim at inoperable kidney cancers
- New test aims to spot kidney cancer early with just a blood or urine sample