"Embolization Before Ablation of Renal Cell Carcinoma (EMBARC)" (NCT05410509) | Clinical Trial Compass
CompletedNot Applicable
"Embolization Before Ablation of Renal Cell Carcinoma (EMBARC)"
United States25 participantsStarted 2024-01-03
Plain-language summary
Multi-center, single arm, prospective trial to estimate safety, feasibility, technical outcomes, and clinical outcomes of percutaneous cryoablation with neo-adjuvant trans-arterial embolization of the tumor in patients with T1b renal cell carcinoma. Continuous safety monitoring will be performed with stopping rules for patient accrual or study continuation.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged ≥18 years
. Solid renal mass consistent with RCC on either ultrasound, MRI, or CT
. Longest tumor diameter measures 4.1-7cm
. Tumor stage T1bN0M0 without vascular invasion, adenopathy, or distant metastatic disease
. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation
. Provision of signed and dated informed consent form
. Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The number of patients experiencing major adverse events defined as anything grade C or above by Society of Interventional Radiology Guidelines.
. Severe renal insufficiency with an Estimated Glomerular Filtration Rate (eGFR) \<30
. Renal cell carcinoma as part of a syndrome
. Horseshoe kidney
. Patient unable to undergo renal mass protocol CT or MRI
. Severe allergy to iodinated contrast not mitigated by steroid and diphenhydramine prophylaxis
. Uncorrectable coagulopathy, including a platelet count of \<30,000/μL and/or an international normalized ratio (INR) \>2.5 that does not respond to platelet transfusion or prothrombin complex concentrate infusion, respectively
. Performance status precludes enrollment as determined by the investigators