Examinations of Tissue From Ablated Malignant Liver Metastases as Predictors of Outcome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Tumor response
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
- •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
Arms & Interventions
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.
Intervention: CT guided percutaneous ablation (Other)
Outcomes
Primary Outcomes
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 Outcomes
- Duration of treatment response(3 years)