NCT04143516

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Metastases

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	[18-F]- FDG - PET	Patients will undergo a limited non-contrast CT and first injection PET to localize the lesion
PROCEDURE	Tumor 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_TEST	PET/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.

Timeline

• Start date: 2019-10-25
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2019-10-29
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study