Clinical trial NCT01012427: Percutaneous Renal Tumor Cryoablation Followed by Biopsy
Official title: Percutaneous Renal Tumor Cryoablation Followed by Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Cancer
Keywords: Kidney
Cryoablation
09-108
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2009-11-13
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: To determine the efficacy rate after percutaneous renal cryoablation.
timeFrame: 2 years
Secondary outcomes:
measure: To determine the complication rate of percutaneous renal tumor cryoablation.
timeFrame: 2 years
measure: To correlate post-treatment imaging parameters of CT/MR with therapeutic cryoablation success.
timeFrame: 2 years
measure: To assess the glomerular filtration rate changes associated with percutaneous renal cryoablation.
timeFrame: 2 years
measure: To investigate predictors of efficacy after cryoablation.
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Stephen Solomon, MD
role: PRINCIPAL_INVESTIGATOR
References: