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New treatment option for Stage I Renal Cell Cancer
Official title Yttrium-90 (Y90) Radioembolization for the Treatment of Early Stage Renal Cell Carcinoma, The RENEGADE Trial
ClinicalTrials.gov ID: NCT06432036
What this study is testing
- What it's testing
- This phase I/II trial tests the safety, side effects and effectiveness of radioembolization with yttrium-90 (Y-90) in patients with early stage renal cell carcinoma. Y-90 is a radioactive chemical that is incorporated into millions of very tiny glass spheres.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Life expectancy ≥ 12 months
- RCC, diagnosed by radiographic imaging and histology
- Clinical stage of RCC: T1 or T2a, Cancer stage (N0M0)
You likely can't join if
- 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...
- Screening angiography demonstrates excessive non-tumoral renal parenchyma will be in the treatment field, that the new baseline glomerular filtration...
- 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...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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
What rules you out
- 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...
- 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-treatment) or during a non-treatment follow-up stage of an treatment study, or prior...
- 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...
- 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...
- History of pulmonary insufficiency, measured by oxygen saturation of less than 90%
- Solitary kidney
- Patient not able to follow the study protocol requirements
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.