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

  • STATUS
    Recruiting
  • End date
    Oct 25, 2024
  • participants needed
    100
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 25 March 2022

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.

Details
Condition Colorectal Cancer Liver Metastases
Treatment PET/CT scan, [18-F]- FDG - PET, Thermal ablation (TA)
Clinical Study IdentifierNCT04143516
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

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%2>
tumors.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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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