Percutaneous Renal Tumor Cryoablation Followed by Biopsy - Full Text View

Purpose

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	Intervention	Phase
Renal Cancer	Procedure: percutaneous cryoablation	Phase 1


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Percutaneous Renal Tumor Cryoablation Followed by Biopsy

Resource links provided by NLM:

MedlinePlus related topics: Biopsy Cancer Kidney Cancer

Genetic and Rare Diseases Information Center resources: Kidney Cancer Renal Cancer

U.S. FDA Resources

Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:

To determine the efficacy rate after percutaneous renal cryoablation. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the complication rate of percutaneous renal tumor cryoablation. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
To correlate post-treatment imaging parameters of CT/MR with therapeutic cryoablation success. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To assess the glomerular filtration rate changes associated with percutaneous renal cryoablation. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To investigate predictors of efficacy after cryoablation. [ Time Frame: 2 years ] [ Designated as safety issue: No ]


Enrollment:	17
Study Start Date:	November 2009
Study Completion Date:	September 2015
Primary Completion Date:	September 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Eligibility


Ages Eligible for Study:	21 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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
Study First Received:	November 11, 2009
Last Updated:	January 4, 2016
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 27, 2016