Percutaneous Renal Tumor Cryoablation Followed by Biopsy
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Renal Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- To determine the efficacy rate after percutaneous renal cryoablation.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
- •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
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.
Outcomes
Primary Outcomes
To determine the efficacy rate after percutaneous renal cryoablation.
Time Frame: 2 years
Secondary Outcomes
- To correlate post-treatment imaging parameters of CT/MR with therapeutic cryoablation success.(2 years)
- To determine the complication rate of percutaneous renal tumor cryoablation.(2 years)
- To investigate predictors of efficacy after cryoablation.(2 years)
- To assess the glomerular filtration rate changes associated with percutaneous renal cryoablation.(2 years)