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

This study is currently recruiting participants.
Verified May 2017 by Memorial Sloan Kettering Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01494324
First Posted: December 19, 2011
Last Update Posted: May 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University of Southern California
Rockefeller University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
  Purpose

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.


Condition Intervention
Liver Cancer Other: CT guided percutaneous ablation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Examinations of Tissue From Ablated Malignant Liver Metastases as Predictors of Outcome

Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • Tumor response [ Time Frame: 3 years ]
    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.


Secondary Outcome Measures:
  • Duration of treatment response [ Time Frame: 3 years ]
    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.


Estimated Enrollment: 160
Study Start Date: October 27, 2009
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 *for patients on Coumadin general clinical guidelines for IR ablation will be followed.
  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01494324


Contacts
Contact: Constantinos Sofocleous, MD 212-639-3379
Contact: Katia Manova, PhD 646-888-2173

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Constantinos Sofocleous, MD    212-639-3379      
Contact: Katia Manova, PhD    646-888-2173      
Principal Investigator: Constantinos Sofocleous, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
University of Southern California
Rockefeller University
Investigators
Principal Investigator: Constantinos Sofocleous, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01494324     History of Changes
Other Study ID Numbers: 09-122
First Submitted: December 13, 2011
First Posted: December 19, 2011
Last Update Posted: May 5, 2017
Last Verified: May 2017

Keywords provided by Memorial Sloan Kettering Cancer Center:
Liver
Thermal Ablation
Dynamic CT
09-122

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases