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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18-F]- FDG - PET | Diagnostic Test | Patients will undergo a limited non-contrast CT and first injection PET to localize the lesion |
|
| 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 |
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Inclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Constantinos Sofocleous, MD, PhD | Contact | 212-639-3379 | sofoclec@mskcc.org | |
| Efsevia Vakiani, MD,PhD | Contact | 646-888-3060 |
| Name | Affiliation | Role |
|---|---|---|
| Constantinos Sofocleous, MD, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41874299 | Derived | 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. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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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.
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| ID | Term |
|---|---|
| D000072078 | Positron Emission Tomography Computed Tomography |
| ID | Term |
|---|---|
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
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This is a single institution prospective study.
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| 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. |
|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |