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NCT Number: NCT04143516

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

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.

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Key information

Conditions

Liver Metastases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Location status: Recruiting

Location contact

Constantinos Sofocleous, MD, PhD

CONTACT

212-639-3379

Constantinos Sofocleous, MD,PhD

PRINCIPAL_INVESTIGATOR

Efsevia Vakiani, MD,PhD

CONTACT

646-888-3060

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[18-F]- FDG - PET

Diagnostic Test

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

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.

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.

Primary outcomes

  1. Tumor response

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Constantinos Sofocleous, MD, PhD

CONTACT

[email protected]

212-639-3379

Efsevia Vakiani, MD,PhD

CONTACT

646-888-3060

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Clinical Trial Optimizing Tumor Ablation for Liver Metastases: Rapid Tissue Analysis Allowing for Immediate Retreatment; Metabolic Imaging Biomarker Validation; and Predictive Genetic Signatures

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Oct 29, 2019
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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