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

Phase 2

Recruiting

• Conditions: Liver Metastases
• Interventions: Diagnostic Test: [18-F]- FDG - PET; Procedure: Tumor ablation (TA); Diagnostic Test: PET/CT Scan

• Registration Number: NCT04143516
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-10-25
• Study First Submitted: 2019-10-25
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-29
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with Liver Metastases	[18-F]- FDG - PET	The standard of care tumor ablation procedure, post-ablation biopsies and pre- and post-ablation PET scans. If the PET scan is positive (shows areas of cancer in the treated metastases), study participants will undergo additional needle biopsies of the positive areas on the scan. If the biopsies show areas of cancer cells that are still alive, the participants will be immediately retreated with a second ablation procedure.
Patients with Liver Metastases	Tumor ablation (TA)	The standard of care tumor ablation procedure, post-ablation biopsies and pre- and post-ablation PET scans. If the PET scan is positive (shows areas of cancer in the treated metastases), study participants will undergo additional needle biopsies of the positive areas on the scan. If the biopsies show areas of cancer cells that are still alive, the participants will be immediately retreated with a second ablation procedure.
Patients with Liver Metastases	PET/CT Scan	The standard of care tumor ablation procedure, post-ablation biopsies and pre- and post-ablation PET scans. If the PET scan is positive (shows areas of cancer in the treated metastases), study participants will undergo additional needle biopsies of the positive areas on the scan. If the biopsies show areas of cancer cells that are still alive, the participants will be immediately retreated with a second ablation procedure.

Primary Outcome Measures

Name	Time	Method
Tumor response	2 years	will be measured according to RECIST and PERCIST 1.0. The first CT and PET scan taken after ablation will be considered the new baseline for subsequent comparisons and measurements.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States