Percutaneous Renal Tumor Cryoablation Followed by Biopsy
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.
|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|
- To determine the efficacy rate after percutaneous renal cryoablation. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|