The purpose of this study is to learn about the safety and side effects of a treatment called yttrium-90 (Y90) radioembolization for a type of kidney cancer called renal cell carcinoma (RCC).
Y90 radioembolization is a procedure that uses a medical device to treat RCC, a type of kidney disease. The treatment uses millions of tiny glass beads that contain a radioactive substance called Y90. These beads are injected into the blood vessels that supply the tumor. This is the first study in people to test this Y90 treatment for RCC. This research is important because it may provide a treatment option for people with stage T1 or T2a RCC who cannot be treated with surgery or ablation. If you decide to join the study, you will first have a visit to see if you qualify. The study team will ask about your medical history and review the results of any biopsy and MRI tests you have had. You will also answer questionnaires about your health, have a physical exam, provide blood samples, and have a CT scan of your chest and stomach area. The CT scan helps doctors see inside your body. You will also have an angiogram, a test that uses special dye and X-rays to show the blood vessels going to your kidney. The dye is injected through a fine hollow tube. If you qualify to join the study, you will receive the Y90 radioembolization procedure. The procedure takes about 2 to 4 hours and is done in the hospital. After the treatment, you will stay for 2 to 6 hours for recovery and then go home the same day. Like the angiogram, a doctor will place a small, thin tube called a catheter into a blood vessel in your leg. The Y90 spheres will then be delivered through the catheter to your tumor. After your treatment, you will return for a follow-up visit with the study doctor 1 day, 1 week, 1 month, and 3 months later. After that, you will have visits every 3 months until 24 months after the procedure. At each visit, you will have a physical exam, blood tests, and fill out questionnaires about your health. Starting at the 3-month visit, you will also have a CT scan. You will be in the study for about 24 months after the procedure. You and your insurance will have to pay for all visits, tests, procedures, and medical care in this study.
You may be able to join this study if you are 18 years of age or older, have RCC, and are expected to live for more than 12 months. You must not be a good candidate for surgery to remove part of your kidney, treatment that uses heat or cold to destroy the tumor, or long-term tumor monitoring of the tumor without treatment. You also must not have tumors in both kidneys.
Protocol Number: 24-1681
More information available at ClinicalTrials.gov: NCT06432036
Principal Investigator