Percutaneous Renal Tumor Cryoablation Followed by Biopsy

Renal Cancer Clinical Trial

Official title:

Percutaneous Renal Tumor Cryoablation Followed by Biopsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01012427
• Other study ID #: 09-108
• Status: Completed
• Phase: Phase 1
• First received: November 11, 2009
• Last updated: January 4, 2016
• Start date: November 2009
• Est. completion date: September 2015

Study information

• Verified date: January 2016
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms
• Renal Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the efficacy rate after percutaneous renal cryoablation.		2 years	No
Secondary	To determine the complication rate of percutaneous renal tumor cryoablation.		2 years	Yes
Secondary	To correlate post-treatment imaging parameters of CT/MR with therapeutic cryoablation success.		2 years	No
Secondary	To assess the glomerular filtration rate changes associated with percutaneous renal cryoablation.		2 years	No
Secondary	To investigate predictors of efficacy after cryoablation.		2 years	No

External Links

•   Memorial Sloan-Kettering Cancer Center