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"Embolization Before Ablation of Renal Cell Carcinoma (EMBARC)"
Recruiting
I'm InterestedTrial ID: NCT05410509
Purpose
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.
Official Title
"Embolization Before Ablation of Renal Cell Carcinoma (EMBARC)"
Stanford Investigator(s)
Nishita Kothary, MD
Professor of Radiology (Interventional Radiology)
Andrew Picel
Clinical Associate Professor, Radiology
Eligibility
Inclusion Criteria:
1. Aged ≥18 years
2. Solid renal mass consistent with RCC on either ultrasound, MRI, or CT
3. Longest tumor diameter measures 4.1-7cm
4. Tumor stage T1bN0M0 without vascular invasion, adenopathy, or distant metastatic disease
5. 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
6. Provision of signed and dated informed consent form
7. Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion Criteria:
1. Pregnancy
2. Severe renal insufficiency with an Estimated Glomerular Filtration Rate (eGFR) \<30
3. Renal cell carcinoma as part of a syndrome
4. Horseshoe kidney
5. Patient unable to undergo renal mass protocol CT or MRI
6. Severe allergy to iodinated contrast not mitigated by steroid and diphenhydramine prophylaxis
7. 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
8. Performance status precludes enrollment as determined by the investigators
Intervention(s):
procedure: Trans-arterial embolization (TAE)
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Christopher Neil Dominguez