Tissue Analysis After Thermal Ablation for Colon Cancer Liver Metastases Leading to Immediate Retreatment
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|ClinicalTrials.gov Identifier: NCT04143516|
Recruitment Status : Recruiting
First Posted : October 29, 2019
Last Update Posted : March 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Liver Metastases||Diagnostic Test: [18-F]- FDG - PET Procedure: Thermal ablation (TA) Diagnostic Test: PET/CT Scan||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a single institution prospective study.|
|Masking:||None (Open Label)|
|Official Title:||Clinical Trial Optimizing Thermal Ablation for Colon Cancer Liver Metastases: Rapid Tissue Analysis Allowing for Immediate Retreatment; Metabolic Imaging Biomarker Validation; and Predictive Genetic Signatures|
|Actual Study Start Date :||October 25, 2019|
|Estimated Primary Completion Date :||October 2023|
|Estimated Study Completion Date :||October 2023|
Experimental: Patients with Colon Cancer Liver Metastases
The standard of care thermal 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
Patients will undergo a limited non-contrast CT and first injection PET to localize the lesion
Procedure: Thermal 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 thermal ablation as per standard IR guidelines. All patients will undergo PET/CT again, within approximately 6 weeks (+/- 2 weeks) of thermal ablation to evaluate for CN in the target tumor(s) or any sign of residual tissue enhancement, representing viable residual tumor and incomplete treatment.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04143516
|Contact: Constantinos Sofocleous, MD, PhDfirstname.lastname@example.org|
|Contact: Efsevia Vakiani, MD||646-888-3060|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Constantinos Sofocleous, MD 212-639-3379|
|Contact: Efsevia Vakiani, MD 646-888-3060|
|Principal Investigator: Constantinos Sofocleous, MD|
|Principal Investigator:||Constantinos Sofocleous, MD, PhD||Memorial Sloan Kettering Cancer Center|