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Active, not recruitingNCT01494324Updated Jan 2, 2026

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

An interventional study of CT guided percutaneous ablation in Liver Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-02.

Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Oct 2009, registered Dec 2011).
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Liver Cancer

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Keywords

  • Liver
  • Thermal Ablation
  • Dynamic CT
  • 09-122
03

In context

Liver Neoplasms

1,392 studies on the registry are indexed under Liver Neoplasms; 346 are open to participants now.

This study's enrollment of 150 is above the median of 47 across 968 interventional studies indexed under Liver Neoplasms.

Browse Liver Neoplasms studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 325 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Enrollment
150 participants (actual)

Study arms

  • 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

Interventions

  • OtherCT 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.

    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.

06

What researchers measure

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.

    Time frame: 3 years

Secondary outcomes

  1. 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.

    Time frame: 3 years

07

Study locations

1 site
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
08

References and documents

Study documents

  • Informed consent form · Apr 12, 2022

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01494324
Lead sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Rockefeller University
Responsible party
Sponsor
First posted
Dec 19, 2011
Start date
Oct 27, 2009
Primary completion
Oct 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Jan 2, 2026

Study contacts

Constantinos Sofocleous, MD
principal investigator · Memorial Sloan Kettering Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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