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Percutaneous Renal Tumor Cryoablation Followed by Biopsy

Primary Purpose

Renal Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
percutaneous cryoablation
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cancer focused on measuring Kidney, Cryoablation, 09-108

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with 3.0 cm or smaller renal cancer

Arm Description

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.

Outcomes

Primary Outcome Measures

To determine the efficacy rate after percutaneous renal cryoablation.

Secondary Outcome Measures

To determine the complication rate of percutaneous renal tumor cryoablation.
To correlate post-treatment imaging parameters of CT/MR with therapeutic cryoablation success.
To assess the glomerular filtration rate changes associated with percutaneous renal cryoablation.
To investigate predictors of efficacy after cryoablation.

Full Information

First Posted
November 11, 2009
Last Updated
January 4, 2016
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01012427
Brief Title
Percutaneous Renal Tumor Cryoablation Followed by Biopsy
Official Title
Percutaneous Renal Tumor Cryoablation Followed by Biopsy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cancer
Keywords
Kidney, Cryoablation, 09-108

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with 3.0 cm or smaller renal cancer
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
percutaneous cryoablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
To determine the efficacy rate after percutaneous renal cryoablation.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
To determine the complication rate of percutaneous renal tumor cryoablation.
Time Frame
2 years
Title
To correlate post-treatment imaging parameters of CT/MR with therapeutic cryoablation success.
Time Frame
2 years
Title
To assess the glomerular filtration rate changes associated with percutaneous renal cryoablation.
Time Frame
2 years
Title
To investigate predictors of efficacy after cryoablation.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Solomon, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan-Kettering Cancer Center

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Percutaneous Renal Tumor Cryoablation Followed by Biopsy

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