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OpenTrials
Completed

NCT Number: NCT01012427

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Percutaneous cryoablation

Procedure

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.

Primary outcomes

  1. To determine the efficacy rate after percutaneous renal cryoablation.

    Time frame: 2 years

Secondary outcomes

  1. To determine the complication rate of percutaneous renal tumor cryoablation.

    Time frame: 2 years

  2. To correlate post-treatment imaging parameters of CT/MR with therapeutic cryoablation success.

    Time frame: 2 years

  3. To assess the glomerular filtration rate changes associated with percutaneous renal cryoablation.

    Time frame: 2 years

  4. To investigate predictors of efficacy after cryoablation.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Nov 13, 2009
Registry last updated
Jan 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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