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Tissue Analysis After Thermal Ablation for Colon Cancer Liver Metastases Leading to Immediate Retreatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04143516
Recruitment Status : Recruiting
First Posted : October 29, 2019
Last Update Posted : February 17, 2022
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:
This study will see whether collecting and analyzing needle biopsy samples from colon cancer liver metastases (CLM) after a thermal 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.

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a single institution prospective study.
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 2024
Estimated Study Completion Date : October 2024
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of colorectal cancer liver metastases (CLM)
  • 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***
  • Any patient with CLM treated with Microwave ablation (as per clinical IR Guidelines)*
  • 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

    • Institutional IR guidelines:

https://one.mskcc.org/sites/pub/radiology/lptestapp/Split%20Dose%20PET%20Ablation%20Liver%20tumors.pdf

  • 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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Constantinos Sofocleous, MD, PhD 212-639-3379 sofoclec@mskcc.org
Contact: Efsevia Vakiani, MD 646-888-3060

Locations
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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         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Constantinos Sofocleous, MD, PhD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04143516    
Other Study ID Numbers: 19-332
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: February 17, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Optimizing Thermal Ablation
Rapid Tissue Analysis
Metabolic Imaging Biomarker Validation
Predictive Genetic Signatures
19-332
Additional relevant MeSH terms:
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Neoplasm Metastasis
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases