Percutaneous Renal Tumor Cryoablation Followed by Biopsy
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01012427 |
Recruitment Status
:
Completed
First Posted
: November 13, 2009
Last Update Posted
: January 5, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Renal Cancer | Procedure: percutaneous cryoablation | Phase 1 |
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 |
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.
|
- To determine the efficacy rate after percutaneous renal cryoablation. [ Time Frame: 2 years ]
- To determine the complication rate of percutaneous renal tumor cryoablation. [ Time Frame: 2 years ]
- To correlate post-treatment imaging parameters of CT/MR with therapeutic cryoablation success. [ Time Frame: 2 years ]
- To assess the glomerular filtration rate changes associated with percutaneous renal cryoablation. [ Time Frame: 2 years ]
- To investigate predictors of efficacy after cryoablation. [ Time Frame: 2 years ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
United States, New York | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10065 |
Principal Investigator: | Stephen Solomon, MD | Memorial Sloan Kettering Cancer Center |
Additional Information:
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 |