RecruitingPhase 2Phase 3NCT04143516

Tissue Analysis After Tumor Ablation for Liver Metastases Leading to Immediate Retreatment

Clinical Trial Optimizing Tumor Ablation for Liver Metastases: Rapid Tissue Analysis Allowing for Immediate Retreatment; Metabolic Imaging Biomarker Validation; and Predictive Genetic Signatures

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

200 participants

Start Date

Oct 25, 2019

Study Type

INTERVENTIONAL

Conditions

Liver Metastases

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria9

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

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.