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

NCT04143516 | Recruiting Phase 2 FDA Device

• 1 other identifier: 19-332
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Metastases

Keywords

Optimizing Tumor Ablation; Rapid Tissue Analysis; Metabolic Imaging Biomarker Validation; Predictive Genetic Signatures; 19-332

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients with Liver Metastases

EXPERIMENTAL

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; Procedure: Tumor ablation (TA); Diagnostic Test: PET/CT Scan

Interventions

[18-F]- FDG - PET DIAGNOSTIC_TEST

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

Patients with Liver Metastases

Tumor ablation (TA) PROCEDURE

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.

Patients with Liver Metastases

PET/CT Scan DIAGNOSTIC_TEST

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.

Patients with Liver Metastases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Related Publications (1)

• Dimopoulos MP, Sotirchos VS, Vakiani E, Sigel C, Petre EN, Kunin H, Kirov AS, Gonen M, Wei A, Soares K, Solomon SB, Schwartz LH, Sofocleous CT. Optimizing Colorectal Liver Metastasis Ablation through Metabolic Imaging, Margin Assessment, and Biopsy (The OPTABLATE Prospective Trial). Radiology. 2026 Mar;318(3):e250864. doi: 10.1148/radiol.250864.

  PMID: 41874299 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Interventions

Positron Emission Tomography Computed Tomography

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Constantinos Sofocleous, MD, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Constantinos Sofocleous, MD, PhD

CONTACT

212-639-3379; sofoclec@mskcc.org

Efsevia Vakiani, MD,PhD

CONTACT

646-888-3060

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single institution prospective study.

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 29, 2019
• Study Start: October 25, 2019
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)