"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 range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
β. Aged β₯18 years
β. Solid renal mass consistent with RCC on either ultrasound, MRI, or CT
β. Longest tumor diameter measures 4.1-7cm
β. Tumor stage T1bN0M0 without vascular invasion, adenopathy, or distant metastatic disease
β. 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
β. Provision of signed and dated informed consent form
β. Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion criteria
β. Pregnancy
β. Severe renal insufficiency with an Estimated Glomerular Filtration Rate (eGFR) \<30
β. Renal cell carcinoma as part of a syndrome
β. Horseshoe kidney
β. Patient unable to undergo renal mass protocol CT or MRI
β. Severe allergy to iodinated contrast not mitigated by steroid and diphenhydramine prophylaxis
β
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.
. Uncorrectable coagulopathy, including a platelet count of \<30,000/ΞΌL and/or an international normalized ratio (INR) \>2.5 that does not respond to platelet transfusion or prothrombin complex concentrate infusion, respectively
β. Performance status precludes enrollment as determined by the investigators