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Trans-arterial Embolization before Percutaneous Cryosurgery for the Treatment of Kidney Cancer
Trial Status: active
This clinical trial studies how well trans-arterial embolization (TAE) before percutaneous cryosurgery (percutaneous cryoablation [PA]) works in treating patients with kidney cancer. TAE is a procedure in which the blood supply to a tumor or an abnormal area of tissue is blocked. During transarterial embolization, a small incision (cut) is made in the inner thigh and a catheter (thin, flexible tube) is inserted and guided into an artery near the tumor or abnormal tissue. Once the catheter is in place, small particles made of tiny gelatin sponges or beads are injected. This blocks the artery and stops the flow of blood to the tumor or abnormal area of tissue. Percutaneous cryosurgery is a procedure where thin needles are inserted through the skin into the tumor under imaging-guidance to freeze the kidney cancer to death (“ablation”). Performing TAE before percutaneous cryosurgery may work better in treating patients with kidney cancer.
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
Pregnancy
Severe renal insufficiency with an 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/uL 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05410509.
I. To estimate the major adverse events from PA with neo-adjuvant TAE of renal cell carcinoma (RCC) in patients with T1b RCC.
II. To estimate the feasibility of patient enrollment in a trial of PA with neo-adjuvant TAE of RCC in patients with T1b RCC.
SECONDARY OBJECTIVES:
I. To estimate the primary technical success of PA with neo-adjuvant TAE of RCC in patients with T1b RCC.
II. To estimate the secondary technical success of PA with neo-adjuvant TAE of RCC in patients with T1b RCC.
III. To estimate the technical success of TAE of RCC in patients with T1b RCC.
IV. To estimate objective response rate (ORR) from PA with neo-adjuvant TAE of RCC in patients with T1b RCC.
V. To estimate change in estimated glomerular filtration rate (eGFR) of PA with neo-adjuvant TAE of RCC in patients with T1b RCC.
VI. To estimate local recurrence rates after PA with neo-adjuvant TAE of RCC in patients with T1b RCC.
VII. To estimate time-to-progression (TTP) after PA with neo-adjuvant TAE of RCC in patients with T1b RCC.
VIII. To estimate cancer-specific survival (CSS) after PA with neo-adjuvant TAE of RCC in patients with T1b RCC.
IX. To estimate overall survival (OS) after PA with neo-adjuvant TAE of RCC in patients with T1b RCC.
TERTIARY/EXPLORATORY OBJECTIVE:
I. To estimate costs (both to the healthcare system and patients) from PA of RCC with neo-adjuvant TAE of the tumor using beads in patients with T1b RCC.
OUTLINE:
Patients undergo TAE and then undergo PA within 30 days. Patients may undergo image guided tissue biopsy and ultrasound imaging during screening. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) during screening and follow up.
After completion of study intervention, patients are followed up at 30-90 days, 6, 12, and 24 months.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUniversity of Alabama at Birmingham Cancer Center
