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Percutaneous Renal Tumor Cryoablation Followed by Biopsy


N/A
21 Years
N/A
Open (Enrolling)
Both
Renal Cancer

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Trial Information

Percutaneous Renal Tumor Cryoablation Followed by Biopsy


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the efficacy rate after percutaneous renal cryoablation.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Stephen Solomon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

09-108

NCT ID:

NCT01012427

Start Date:

November 2009

Completion Date:

November 2014

Related Keywords:

  • Renal Cancer
  • Kidney
  • Cryoablation
  • 09-108
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021