Percutaneous Renal Tumor Cryoablation Followed by Biopsy

Completed · Phase 1

Conditions studied: Renal Cancer

In brief

This study is being done to test how effective cryoablation is in killing cancer cells. Cryoablation uses freezing temperatures to treat cancer. Cryoablation works by creating freezing temperatures within a needle probe. When this probe is inserted into a cancer, the freezing temperatures are used to try and kill the cancer. Unfortunately, the investigators don't know how well cryoablation works at destroying the cancer. This study will allow us to check to see how well cryoablation works for kidney cancers. After the investigators destroy the kidney cancers using cryoablation, the investigators will followup with you every 5-7 months to make sure the cryoablation worked and that the cancer was destroyed.

Key facts

Study ID

NCT01012427

Run by

Memorial Sloan Kettering Cancer Center

People needed

17

Starts

2009-11-01

Expected to finish

2015-09-01

Last updated by the study team

2016-01-05

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Presence of at least one renal cancer smaller than or equal to 3.0 cm
• Adequate baseline imaging studies (CT/MRI) within 8 weeks of treatment or as clinically indicated.
• The following laboratory results should be within the following limits within the last 30 days prior to study day 1. Repeat blood work will be necessary if too much time has elapsed prior to the interventions.:
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
• Platelet count ≥ 100 x 109/L
• Serum bilirubin ≤ 2.0 mg/dL
• Aspartate aminotransaminase (AST) ≤ 2.5 x ULN
• Alanine aminotransferase (ALT) ≤ 2.5 x ULN
• Serum creatinine ≤ 2.0 mg/dL
• GFR >30 mL/min/m2
• International Normalized Ratio < 1.5 (INR)
• Partial Thromboplastin Time (PTT) <45 seconds
• Recovered from toxicity of any prior therapy
• Tumor accessible to probe placement without risk to adjacent critical structures.
• Tumor visible on non-contrast CT
• Patient willing and able to undergo imaging and percutaneous biopsy at 5-7 month intervals for 2 years and then at the discretion of the patient's physicians.

You may not qualify if…

• Intercurrent medical condition that renders the patient ineligible for cryoablation
• Women who are pregnant or breastfeeding.
• Tumor less than 5 mm to the renal pelvis, main renal vessel, ureter, or other vital structure
• Contraindication to MRI in patients in which it is required.
• Coagulopathy as defined above (Inclusion Criteria).
• Patients unwilling to return for follow-up biopsy and imaging.

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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