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

NCT01494324 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-01-02

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Constantinos Sofocleous, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-27
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01494324 on ClinicalTrials.gov