Back to resultsExaminations of Tissue From Ablated Malignant Liver Metastases as Predictors of Outcome
Primary Purpose
Liver Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CT guided percutaneous ablation
Sponsored by
About this trial
This is an interventional diagnostic trial for Liver Cancer focused on measuring Liver, Thermal Ablation, Dynamic CT, 09-122
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)
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
Sites / Locations
- Memorial Sloan Kettering Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CT guided percutaneous ablation
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01494324
First Posted
December 13, 2011
Last Updated
April 14, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Rockefeller University
1. Study Identification
Unique Protocol Identification Number
NCT01494324
Brief Title
Examinations of Tissue From Ablated Malignant Liver Metastases as Predictors of Outcome
Official Title
Examinations of Tissue From Ablated Malignant Liver Metastases as Predictors of Outcome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 27, 2009 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Rockefeller University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
Liver, Thermal Ablation, Dynamic CT, 09-122
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CT guided percutaneous ablation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
CT guided percutaneous ablation
Other Intervention Name(s)
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.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tumor response
Description
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 Outcome Measure Information:
Title
Duration of treatment response
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Constantinos Sofocleous, MD
Phone
212-639-3379
First Name & Middle Initial & Last Name or Official Title & Degree
Katia Manova, PhD
Phone
646-888-2173
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Constantinos Sofocleous, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Constantinos Sofocleous, MD
Phone
212-639-3379
First Name & Middle Initial & Last Name & Degree
Katia Manova, PhD
Phone
646-888-2173
First Name & Middle Initial & Last Name & Degree
Constantinos Sofocleous, MD
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
Examinations of Tissue From Ablated Malignant Liver Metastases as Predictors of Outcome
We'll reach out to this number within 24 hrs