A Study Using Tissue Biopsy and PET Scanning to Optimize Thermal Ablation for Colon Cancer Liver Metastases

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Full Title

Clinical Trial Optimizing Tumor Ablation for Liver Metastases: Rapid Tissue Analysis Allowing for Immediate Retreatment; Metabolic Imaging Biomarker Validation; and Predictive Genetic Signatures

Purpose

When some cancers become advanced, particularly colorectal cancer, they may spread to the liver. Destroying the tissue with electromagnetic waves that produce extremely high temperatures, a procedure called “thermal ablation,” is one way to treat these liver metastases.

When doctors treat patients with thermal ablation for liver metastases, they use imaging to confirm whether the entire tumor has been treated. PET scanning may detect active living cancer cells not seen by CT scanning or ultrasound. A biopsy of the treated tumor can also detect residual living tissue that is not visible with imaging immediately after ablation.

Researchers think that examining tissue samples from treated metastases right after ablation may show whether any cancer cells are still alive. Doctors could combine PET/CT and biopsy findings to determine if immediate retreatment of these areas with a second round of thermal ablation is needed. This assessment and retreatment is not the current standard of care; its goal is to enhance the success of ablation for the treatment of cancer.

In this study, researchers will evaluate this approach. Patients with liver metastases from colorectal cancer that can be treated with thermal ablation are eligible for enrollment. After the ablation procedure, they will have a PET scan of the treated area(s), and the doctor will collect samples of the tissue from these areas using needle biopsy. If the scan and the tissue samples both show that there are still living cancer cells in the treated areas, these areas will then be immediately retreated with ablation. It is hoped that this treatment approach will improve patient outcomes.

Who Can Join

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have liver metastases (each 3 cm or less in largest diameter).
  • Patients must have planning to have thermal ablation.
  • Patients must be age 18 or older.

For more information and to inquire about eligibility for this study, please contact Dr. Constantinos Sofocleous at 212-639-3379.

Protocol

19-332

Phase

Phase II/III (phases 2 and 3 combined)

Disease Status

Relapsed or Refractory

Co-Investigators

ClinicalTrials.gov ID

NCT04143516