Analyzing liver tumor tissue after ablation to guide further treatment
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
Run by Memorial Sloan Kettering Cancer Center · NCT04143516 · Data updated 2026-11-12
This study is testing if looking at liver tumor samples after treatment can help doctors decide the best next steps for patients with liver cancer.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | October 25, 2019 |
| Main results expected | October 2027 |
| Study ends | October 2027 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT04143516 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults diagnosed with liver metastases from various primary tumors who meet specific health criteria.
✕Probably not a fit
Patients under 18 years old or those with extensive liver or extrahepatic disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to collect and analyze needle biopsy samples from liver metastases following a tumor ablation procedure. By identifying any remaining cancer cells in these samples, the study seeks to inform subsequent treatment decisions for patients. The methodology involves using metabolic imaging and predictive genetic signatures to optimize treatment strategies. The study will assess the effectiveness of these approaches in improving patient outcomes.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment plans for patients with liver metastases.
How similar studies have gone: Other studies have shown promise in using tissue analysis and imaging techniques for cancer treatment optimization, suggesting a potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Memorial Sloan Kettering Cancer Center
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Constantinos Sofocleous, MD, PhD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Constantinos Sofocleous, MD, PhD
- Email: sofoclec@mskcc.org
- Phone: 212-639-3379
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.