Examinations of Tissue From Ablated Malignant Liver Metastases as Predictors of Outcome

The purpose of this study is to see if the investigators can do some tests on tissue from the area of the ablation. The investigators want to know if a test can help predict whether the ablation worked.

The treated tumor is normally evaluated with CT. The CT shows signs of treated tumor(s) in the area treated by ablation. However, cancer cells may begin to grow in or near the treated area. The CT scan cannot tell us if the cells are new cancer cells or if they are healthy liver cells that just look different because of the ablation. The test the investigators will study should be able to tell us the difference.

Study Overview

• Status: Recruiting
• Conditions: Liver Cancer
• Intervention / Treatment: Other: CT guided percutaneous ablation

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katia Manova, PhD; Phone Number: 646-888-2173
• Study Contact Backup: Name: Constantinos Sofocleous, MD; Phone Number: 212-639-3379

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Katia Manova, PhD; Phone Number: 646-888-2173
      • Contact: Constantinos Sofocleous, MD; Phone Number: 212-639-3379
      • Principal Investigator: Constantinos Sofocleous, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with diagnosed with secondary hepatic malignancy;
• Patients with confined liver disease or stable limited extrahepatic disease;
• Lesions of 5cm or less in maximum diameter;
• Patients who are not surgical candidates or refuse to undergo surgery and choose any percutaneous ablation as an alternative treatment option.
• INR<1.5 *for patients on Coumadin general clinical guidelines for IR ablation will be followed.
• Platelet count > or = to 50,000

Exclusion Criteria:

• Patients < 18
• Less than 5 mm distance of the tumor margin from a major vessel >7mm in diameter)**
• Less than 5 mm distance to a structure (GI or biliary tract), that cannot be protected from**
• the ablation injury with technical modifications such as hydro or air dissection.
• INR > 1.5 that cannot be corrected with fresh frozen Plasma*
• Platelet count of <50,000 that cannot be corrected with transfusion.
• Patient with more than 3 tumors treated with any percutaneous ablation

• Patients with more than 5 sites of extrahepatic disease (including nodes and pulmonary nodules)

  • for patients on Coumadin general clinical guidelines for IR ablation will be followed **This will not be considered an exclusion criteria when IRE or Microwave is used.

    • This will not be considered exclusion when IRE is used

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CT guided percutaneous ablation; The selected patients will undergo CT guided percutaneous ablation. The use of multi-tined electrode is encouraged, unless tumor location requires the use of an internally cooled needle electrode to eliminate injury to an adjacent vital structure or the operator prefers to use an internally cooled electrode for a specific reason.

Other: CT guided percutaneous ablation; Depending on tumor size and location, we will direct a core biopsy needle in the ablated tumor using post-ablation dynamic Liver CT guidance, preferably including liver triphasic examination. The obtained tissue will be detached, collected and submitted to our molecular cytology laboratory. All specimens will be submitted fresh to our molecular cytology laboratory for immediate analysis in order to classify them as viable tumor (V) or apoptotic cells/coagulation necrosis (CN). CT will be performed within 24 hours of the ablation to demonstrate the ablation defect, representing the area of coagulation necrosis. This CT will be used for targeting the ablated tumor for biopsy. All patients will undergo CT again, approximately within 4-8 weeks (+/- 2 weeks) of percutaneous ablation to evaluate for CN in the target tumor or any sign of residual tissue enhancement, representing incomplete treatment.; Other Names: Follow-up will continue at approximate 2-4 months intervals (+/- 2 weeks) with CT, to evaluate for local tumor progression (LTP) for the following 3 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor response	will be measured according to EASL and RECIST. In the case of differences between these criteria, the EASL criteria will be used for clinical judgment and decisions.Tumor response will be determined at the discretion of the Principal Investigator in the case of overlapping ablation zones or lesions seen only in PET.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of treatment response	will be measured as the time from the date of first objective response until the first measurement of progression as determined by the central readers using the EASL criteria. Dynamic Liver CT scans, preferably including the liver triphasic examination will be conducted at each follow-up visit until progression.	3 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Rockefeller University
• Investigators: Principal Investigator: Constantinos Sofocleous, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2009
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: December 13, 2011
• First Submitted That Met QC Criteria: December 14, 2011
• First Posted (Estimated): December 19, 2011

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Liver; Thermal Ablation; Dynamic CT; 09-122
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: 09-122