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NCT04143516 | RECRUITING | Liver Metastases

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

Memorial Sloan Kettering Cancer Center

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.

Condition or disease

Liver Metastases

Intervention/treatment

[18-F]- FDG - PET

Tumor ablation (TA)

PET/CT Scan

Phase

PHASE2

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : Clinical Trial Optimizing Tumor Ablation for Liver Metastases: Rapid Tissue Analysis Allowing for Immediate Retreatment; Metabolic Imaging Biomarker Validation; and Predictive Genetic Signatures
Actual Study Start Date : 2019-10-25
Estimated Primary Completion Date : 2026-10
Estimated Study Completion Date : 2026-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Tissue Analysis After Tumor Ablation for Liver Metastases Leading to Immediate Retreatment

Location Details

NCT04143516

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065