Examinations of Tissue From Ablated Malignant Liver Metastases as Predictors of Outcome
| Status: | Recruiting |
|---|---|
| Conditions: | Liver Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/4/2018 |
| Start Date: | October 27, 2009 |
| End Date: | October 2019 |
| Contact: | Constantinos Sofocleous, MD |
| Phone: | 212-639-3379 |
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.
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.
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.
We found this trial at
1
site
1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Principal Investigator: Constantinos Sofocleous, MD
Phone: 212-639-3379
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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