Examinations of Tissue From Ablated Malignant Liver Metastases as Predictors of Outcome
|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.|
|ClinicalTrials.gov Identifier: NCT01494324|
Recruitment Status : Recruiting
First Posted : December 19, 2011
Last Update Posted : May 1, 2019
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 or disease||Intervention/treatment||Phase|
|Liver Cancer||Other: CT guided percutaneous ablation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Examinations of Tissue From Ablated Malignant Liver Metastases as Predictors of Outcome|
|Study Start Date :||October 27, 2009|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
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.
- 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.
- 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.
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
|Contact: Constantinos Sofocleous, MD||212-639-3379|
|Contact: Katia Manova, PhD||646-888-2173|
|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|
|Principal Investigator:||Constantinos Sofocleous, MD||Memorial Sloan Kettering Cancer Center|