Study on Yttrium-90 Radioembolization for Treating Early Stage Kidney Cancer (The RENEGADE Trial)
Sponsor: Jonsson Comprehensive Cancer Center
ClinicalTrials ID:NCT06432036
This clinical trial is exploring the safety and effectiveness of a treatment called radioembolization using a radioactive substance, Yttrium-90, for patients with early stage kidney cancer. The treatment involves injecting tiny radioactive spheres into the artery that supplies blood to the cancer.
Patient Parameters
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Program Overview
The purpose of this study is to test if radioembolization with Yttrium-90 (Y-90) is a safe and effective treatment for patients with early stage kidney cancer, known as renal cell carcinoma. Y-90 is a radioactive material that is placed into tiny glass spheres. These spheres are injected into the artery that feeds the cancer, a process called radioembolization. This study will help determine if this method can safely reduce or control the cancer.
Description
The main goal of this study is to see if Yttrium-90 radioembolization is safe for treating kidney cancer. Researchers will also look at how well the cancer responds to the treatment, how long the response lasts, and how long patients live without the cancer getting worse. They will also monitor kidney function and quality of life before and after treatment.
Participants will receive the Y-90 treatment through an injection into the artery that supplies blood to the cancer. They will have various tests, including scans and blood tests, to monitor their health and the treatment's effects. After the treatment, participants will have follow-up visits at 1 day, 1 week, and then monthly for up to 24 months to check on their progress.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must provide written consent to participate.
- Must have a life expectancy of at least 12 months.
- Must have early stage kidney cancer diagnosed by imaging and biopsy.
- Must have 1-2 solid tumors that are mostly solid.
- Not suitable for surgery or other treatments due to medical reasons.
- Not suitable for long-term monitoring due to cancer risk.
- Must have measurable tumors by standard criteria.
- Must not have tumors in both kidneys.
- Women of childbearing age must have a negative pregnancy test and not be breastfeeding.
- Must have certain blood counts and kidney function levels.
- Must be in good general health with a performance status of 0 or 1.
- Must have a successful angiogram showing the tumor can be targeted with Y-90.
Exclusion Criteria
- Cannot have conditions that prevent safe angiography or artery catheterization.
- Cannot have blood flow to the stomach or intestines that cannot be corrected.
- Cannot have poor targeting of the tumor that would result in an incorrect dose.
- Cannot have excessive healthy kidney tissue in the treatment area.
- Cannot have cancer that has spread outside the kidney.
- Cannot have brain or spinal cord cancer.
- Cannot have cancer invading the kidney's blood vessels or collecting system.
- Cannot have had prior radiation to the abdomen.
- Cannot be receiving other treatments for kidney cancer.
- Cannot have a history of immune system deficiencies.
- Cannot have a kidney stent.
- Cannot have had another cancer within three years, except for certain skin or localized cancers.
- Cannot have had major surgery within 28 days before joining the study.
- Cannot have severe allergies to certain medications.
- Cannot have active infections.
- Women who are pregnant or breastfeeding cannot participate.
- Cannot have unstable chronic diseases or conditions that increase risk.
- Cannot have low oxygen levels.
- Cannot have only one kidney.
- Must be able to follow study requirements.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | 90095 | Los Angeles | California |
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