Analyzing liver tumor tissue after ablation to guide further treatment
Clinical Trial Optimizing Tumor Ablation for Liver Metastases: Rapid Tissue Analysis Allowing for Immediate Retreatment; Metabolic Imaging Biomarker Validation; and Predictive Genetic Signatures
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 |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04143516 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with liver metastases from various primary tumors who meet specific health criteria.
Not a fit: Patients under 18 years old or those with extensive liver or extrahepatic disease may not benefit from this study.
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 performed: Other studies have shown promise in using tissue analysis and imaging techniques for cancer treatment optimization, suggesting a potential for success in this approach.
Eligibility criteria
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 this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.