Percutaneous Renal Tumor Cryoablation Followed by Biopsy

Phase 1

Completed

• Conditions: Renal Cancer

• Registration Number: NCT01012427
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-11
• Study First Submitted QC: 2009-11-12
• Study First Posted: 2009-11-13
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-04
• Last Update Posted: 2016-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine the efficacy rate after percutaneous renal cryoablation.	2 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States