Liver Metastases
Conditions
Keywords
Optimizing Tumor Ablation, Rapid Tissue Analysis, Metabolic Imaging Biomarker Validation, Predictive Genetic Signatures, 19-332
Brief 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.
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
This is a single institution prospective study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 corrected with fresh frozen plasma \*\* * Platelet count of \<50,000 that cannot be corrected with transfusion * More than 3 tumors in the liver * More than 5 tumors of extrahepatic disease (including mediastinal nodes and pulmonary nodules, abdominal or other lymph nodes, and bone metastasis) * Presence of any peritoneal Carcinomatosis * For patients on Coumadin, general clinical guidelines for IR ablation will be followed. * For patients with no FDG-PET avid tumors aim 2 of the protocol will not be assessed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor response | 2 years | will be measured according to RECIST and PERCIST 1.0. The first CT and PET scan taken after ablation will be considered the new baseline for subsequent comparisons and measurements. |
Countries
United States
Contacts
CONTACTConstantinos Sofocleous, MD, PhD
CONTACTEfsevia Vakiani, MD,PhD
PRINCIPAL_INVESTIGATORConstantinos Sofocleous, MD, PhD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed