Tissue Analysis After Tumor Ablation for Liver Metastases Leading to Immediate Retreatment
Recruiting now · Phase 2/Phase 3
Conditions studied: Liver Metastases
In brief
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.
Key facts
- Study ID
- NCT04143516
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 200
- Starts
- 2019-10-25
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2026-03-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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