Clinical trial · Interventional
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
NCT04143516CI-TRIAL-00106046recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Metastases | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18-F]- FDG - PET | Diagnostic Test | — | UNRESOLVED |
| PET/CT Scan | Diagnostic Test | — | UNRESOLVED |
| Tumor ablation (TA) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with Liver Metastases
- 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.
- interventionNames
- Diagnostic Test: [18-F]- FDG - PET
- Procedure: Tumor ablation (TA)
- Diagnostic Test: PET/CT Scan
Primary outcomes (1)
- measure
- Tumor response
- timeFrame
- 2 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 assessedReferences
Publications (1)
- DERIVEDDimopoulos 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