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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Liver Metastases

Treatments: Diagnostic Test: PET/CT Scan; Diagnostic Test: [18-F]- FDG - PET; Procedure: Tumor ablation (TA)

Study type: Interventional

Funder types: Other

Identifiers

NCT04143516

19-332

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Patients with Liver Metastases

Experimental group

Description:

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.

Treatment:

Procedure: Tumor ablation (TA)

Diagnostic Test: [18-F]- FDG - PET

Diagnostic Test: PET/CT Scan