Percutaneous Renal Tumor Cryoablation Followed by Biopsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01012427
Recruitment Status : Completed
First Posted : November 13, 2009
Last Update Posted : January 5, 2016
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

November 11, 2009
November 13, 2009
January 5, 2016
November 2009
September 2015   (Final data collection date for primary outcome measure)
To determine the efficacy rate after percutaneous renal cryoablation. [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT01012427 on Archive Site
  • To determine the complication rate of percutaneous renal tumor cryoablation. [ Time Frame: 2 years ]
  • To correlate post-treatment imaging parameters of CT/MR with therapeutic cryoablation success. [ Time Frame: 2 years ]
  • To assess the glomerular filtration rate changes associated with percutaneous renal cryoablation. [ Time Frame: 2 years ]
  • To investigate predictors of efficacy after cryoablation. [ Time Frame: 2 years ]
Same as current
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Percutaneous Renal Tumor Cryoablation Followed by Biopsy
Percutaneous Renal Tumor Cryoablation Followed by Biopsy
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.
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Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Renal Cancer
Procedure: percutaneous cryoablation
All patients will have percutaneous image guided core biopsies of the treatment site and CT or MR imaging at approximately 5-7 months following the cryoablation. They will have repeat imaging every 5-7 months for a period of two years, and if there is evidence of recurrence (ablation zone increase > 5 mm or increased enhancement 15 HU), then repeat biopsy will be obtained. Imaging follow-up past the two year point will be at the discretion of the patient's physicians.
Experimental: Patients with 3.0 cm or smaller renal cancer
The interventions in this study are part of clinical care and include percutaneous image-guided biopsy, percutaneous renal tumor cryoablation, CT/MR imaging of the ablation bed, and repeat pathologic sampling of the tumor bed with percutaneous biopsy. The cryoablation is done as the therapeutic intervention in patients with small renal cancer. The CT/MR imaging is done to evaluate the treatment for residual disease after the ablation. The repeat biopsy (e.g. three cores) is done to confirm that the neoplasm has been eradicated. These patients have continued imaging, and if necessary, percutaneous biopsy to ensure no recurrent disease.
Intervention: Procedure: percutaneous cryoablation
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2015
September 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
21 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
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Principal Investigator: Stephen Solomon, MD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP