- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01012427
Percutaneous Renal Tumor Cryoablation Followed by Biopsy
January 4, 2016 updated by: Memorial Sloan Kettering Cancer Center
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the efficacy rate after percutaneous renal cryoablation.
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the complication rate of percutaneous renal tumor cryoablation.
Time Frame: 2 years
|
2 years
|
To correlate post-treatment imaging parameters of CT/MR with therapeutic cryoablation success.
Time Frame: 2 years
|
2 years
|
To assess the glomerular filtration rate changes associated with percutaneous renal cryoablation.
Time Frame: 2 years
|
2 years
|
To investigate predictors of efficacy after cryoablation.
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Stephen Solomon, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
November 11, 2009
First Submitted That Met QC Criteria
November 12, 2009
First Posted (Estimate)
November 13, 2009
Study Record Updates
Last Update Posted (Estimate)
January 5, 2016
Last Update Submitted That Met QC Criteria
January 4, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-108
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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