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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Metastases
• Intervention / Treatment: Diagnostic test: [18-F]- FDG - PET; Procedure: Tumor ablation (TA); Diagnostic test: PET/CT Scan

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Constantinos Sofocleous, MD, PhD; Phone Number: 212-639-3379; Email: sofoclec@mskcc.org
• Study Contact Backup: Name: Efsevia Vakiani, MD; Phone Number: 646-888-3060

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Efsevia Vakiani, MD; Phone Number: 646-888-3060
      • Contact: Constantinos Sofocleous, MD; Phone Number: 212-639-3379
      • Principal Investigator: Constantinos Sofocleous, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with Liver Metastases; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor response	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.	2 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Constantinos Sofocleous, MD, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2019
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: October 25, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Rapid Tissue Analysis; Metabolic Imaging Biomarker Validation; Predictive Genetic Signatures; 19-332; Optimizing Tumor Ablation
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Neoplastic Processes; Neoplasm Metastasis; Liver Neoplasms
• Other Study ID Numbers: 19-332

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No