Clinical Trial Optimizing Tumor Ablation for Liver Metastases: Rapid Tissue Analysis Allowing for Immediate Retreatment; Metabolic Imaging Biomarker Validation; and Predictive Genetic Signatures
Memorial Sloan Kettering Cancer Center
Summary
This study will see whether collecting and analyzing needle biopsy samples from cancer liver metastases after a tumor ablation procedure will be able to identify cancer cells that are still alive. The results of these biopsies could help determine the next treatment for your cancer, but the biopsies could cause side effects.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosis of liver metastases from various primary tumors * Confined liver disease or limited extrahepatic disease stable/controlled for at least 4 months (extrahepatic disease amenable to treatment is allowed) * Lesions of ≤3 cm in maximum diameter * At least one FDG-avid lesion to be treated\*\*\* * INR \< 1.5\* * Platelet count ≥ 50,000 Exclusion Criteria: * Age \< 18 * Less than 5 mm distance to a structure (GI or biliary tract), that cannot be protected from ablation injury with technical modifications such as hydro or air dissection * INR \> 1.5 that cannot be co…
Interventions
- Diagnostic Test[18-F]- FDG - PET
Patients will undergo a limited non-contrast CT and first injection PET to localize the lesion
- ProcedureTumor ablation (TA)
Standard ablation with the intent to create a radius of ablation at least 10 mm larger than the largest lesion diameter in order to achieve a minimum of 5 mm ablation margin around the tumor. Any radiographically-identified and biopsy-confirmed residual tumor will be treated on site with immediate ablation. This repeat ablation is not standard of care but will be performed as described for the initial ablation (in the same procedure session) and follow up will be resumed.
- Diagnostic TestPET/CT Scan
Eligible patients will undergo PET/CT -guided tumor ablation as per standard IR guidelines. All patients will undergo PET/CT again, within approximately 6 weeks (+/- 2 weeks) of tumor ablation to evaluate for CN in the target tumor(s) or any sign of residual tissue enhancement, representing viable residual tumor and incomplete treatment.
Location
- Memorial Sloan Kettering Cancer CenterNew York, New York