Tissue Analysis After Tumor Ablation for Liver Metastases Leading to Immediate Retreatment
Recruiting
Phase 2Phase 3Interventional Study
Liver Metastases
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Diagnostic
Participants needed
200 (estimated)
Sponsor
Memorial Sloan Kettering Cancer Center · Other
Who this trial is looking for
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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.
Trial Locations
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Eligibility 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 les…
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
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