Menu
Recruiting NCT04143516

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

Phase II / Phase III Interventional Liver Metastases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: [18-F]- FDG - PET, Tumor ablation (TA), PET/CT Scan.
Who it may be relevant to
Registry conditions: Liver Metastases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Tumor response [Time frame: 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Memorial Sloan Kettering Cancer Center — New York

Publications

  • 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

Identifiers

NCT: NCT04143516 · 19-332

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗