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Percutaneous Renal Tumor Cryoablation Followed by Biopsy

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ClinicalTrials.gov Identifier: NCT01012427
Recruitment Status : Completed
First Posted : November 13, 2009
Last Update Posted : January 5, 2016
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Renal Cancer Procedure: percutaneous cryoablation Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Percutaneous Renal Tumor Cryoablation Followed by Biopsy
Study Start Date : November 2009
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

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Arms and Interventions
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Arm Intervention/treatment
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. To determine the efficacy rate after percutaneous renal cryoablation. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. To determine the complication rate of percutaneous renal tumor cryoablation. [ Time Frame: 2 years ]
  2. To correlate post-treatment imaging parameters of CT/MR with therapeutic cryoablation success. [ Time Frame: 2 years ]
  3. To assess the glomerular filtration rate changes associated with percutaneous renal cryoablation. [ Time Frame: 2 years ]
  4. To investigate predictors of efficacy after cryoablation. [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01012427


Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Stephen Solomon, MD Memorial Sloan Kettering Cancer Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Memorial Sloan-Kettering Cancer Center  This link exits the ClinicalTrials.gov site

Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01012427     History of Changes
Other Study ID Numbers: 09-108
First Posted: November 13, 2009    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: January 2016

Keywords provided by Memorial Sloan Kettering Cancer Center:
Kidney
Cryoablation
09-108

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type