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

NCT ID: NCT01494324

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-27
• Study Completion Date: 2026-10-31

Brief Summary

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.

Conditions

Liver Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC

Study Groups

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.

Group Type: EXPERIMENTAL

CT guided percutaneous ablation

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention 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.

Eligibility Criteria

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)

• This will not be considered exclusion when IRE is used

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rockefeller University

OTHER

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Constantinos Sofocleous, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Related Links

http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

09-122

Identifier Type: -

Identifier Source: org_study_id