Percutaneous Renal Tumor Cryoablation Followed by Biopsy

NCT01012427 | Completed Phase 1

• 1 other identifier: 09-108
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Cancer

Keywords

Kidney; Cryoablation; 09-108

Outcome Measures

Primary Outcomes (1)

• To determine the efficacy rate after percutaneous renal cryoablation.

  2 years

Secondary Outcomes (4)

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

  2 years

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

  2 years

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

  2 years

• To investigate predictors of efficacy after cryoablation.

  2 years

Study Arms (1)

Patients with 3.0 cm or smaller renal cancer

EXPERIMENTAL

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

Interventions

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.

Patients with 3.0 cm or smaller renal cancer

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Patients unwilling to return for follow-up biopsy and imaging.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Stephen Solomon, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2009
• First Posted: November 13, 2009
• Study Start: November 1, 2009
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 5, 2016

Record last verified: 2016-01

Locations

US (1)