Status:
RECRUITING
"Embolization Before Ablation of Renal Cell Carcinoma (EMBARC)"
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Varian, a Siemens Healthineers Company
Conditions:
Renal Cell Carcinoma (RCC)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- Pregnancy
- 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
Key Trial Info
Start Date :
January 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05410509
Start Date
January 3 2024
End Date
December 31 2027
Last Update
December 29 2025
Active Locations (4)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Stanford Cancer Institute
Stanford, California, United States, 94305
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
4
Thomas Jefferson Health
Philadelphia, Pennsylvania, United States, 19107