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

NCT01494324 | Active Not Recruiting

• 1 other identifier: 09-122
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

Liver; Thermal Ablation; Dynamic CT; 09-122

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Duration of treatment response

  3 years

Study Arms (1)

CT guided percutaneous ablation

EXPERIMENTAL

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

Interventions

CT guided percutaneous ablation 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.

Also known as: 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.

CT guided percutaneous ablation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Rockefeller University: collaborator

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

Liver Neoplasms

Interventions

Long-Term Potentiation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Constantinos Sofocleous, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: December 19, 2011
• Study Start: October 27, 2009
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

US (1)