RecruitingPhase 2Phase 3NCT04143516

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

Clinical Trial Optimizing Tumor Ablation for Liver Metastases: Rapid Tissue Analysis Allowing for Immediate Retreatment; Metabolic Imaging Biomarker Validation; and Predictive Genetic Signatures

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

200 participants

Start Date

Oct 25, 2019

Study Type

INTERVENTIONAL

Conditions

Liver Metastases

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment approach where a small device is implanted into liver metastases (cancer that has spread to the liver from another location) during an ablation procedure (a technique that destroys tumors using heat or cold). The device helps the doctor immediately see if the ablation was complete — and if not, retreat on the spot. **You may be eligible if...** - You have cancer that has spread to the liver (liver metastases) from any primary tumor - Your cancer is limited to the liver, or any cancer outside the liver has been stable for at least 4 months - The liver tumors are 3 cm or smaller - You have no more than 3 tumors in the liver - Your blood clotting and platelet levels are acceptable **You may NOT be eligible if...** - You are under 18 - Your tumor is too close (less than 5 mm) to the intestine or bile duct and cannot be safely separated - You have more than 3 liver tumors - You have more than 5 spots of cancer outside the liver - You have cancer spreading throughout the lining of the abdomen (peritoneal carcinomatosis) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TEST[18-F]- FDG - PET

Patients will undergo a limited non-contrast CT and first injection PET to localize the lesion

PROCEDURETumor ablation (TA)

Standard ablation with the intent to create a radius of ablation at least 10 mm larger than the largest lesion diameter in order to achieve a minimum of 5 mm ablation margin around the tumor. Any radiographically-identified and biopsy-confirmed residual tumor will be treated on site with immediate ablation. This repeat ablation is not standard of care but will be performed as described for the initial ablation (in the same procedure session) and follow up will be resumed.

DIAGNOSTIC_TESTPET/CT Scan

Eligible patients will undergo PET/CT -guided tumor ablation as per standard IR guidelines. All patients will undergo PET/CT again, within approximately 6 weeks (+/- 2 weeks) of tumor ablation to evaluate for CN in the target tumor(s) or any sign of residual tissue enhancement, representing viable residual tumor and incomplete treatment.