Percutaneous Renal Tumor Cryoablation Followed by Biopsy
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2009 |
| End Date: | September 2015 |
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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