A Study to See if we Can Predict How Your Liver Tumor or Liver Metastases Will Respond to Trans-Arterial Embolization (TAE)

Study Overview
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Brief Summary
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The purpose of this study is to see if certain genes the tumor can help predict how the tumor will respond to Trans-Arterial Embolization (TAE). A gene is the basic physical and functional unit of heredity. Genes are made up of DNA; DNA (deoxyribonucleic acid) is the hereditary material in humans. Identifying a gene that can predict how liver tumors will respond to TAE will also help to determine if adjuvant therapy will be needed after TAE.

Official Title
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A PILOT STUDY TO IDENTIFY MOLECULAR PREDICTORS OF SENSITIVITY AND RESISTANCE TO TRANS-ARTERIAL EMBOLIZATION OF PRIMARY LIVER TUMORS AND LIVER METASTASES

Conditions
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Liver Cancer, Liver Metastases

Intervention / Treatment
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* Procedure: Hepatic trans-arterial embolization (TAE)
* Device: MRI/CT scan
* Procedure: biopsy
* Other: blood draw


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histopathologic evidence of primary liver cancer or liver metastases Indication of TAE for the treatment of liver tumor Age ≥ 18 years Available tissue with adequate tissue for analysis, verified by a pathologist Exclusion Criteria: History of a second active malignancy with evidence of metastatic disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with primary liver or liver metastases<br>A biopsy will be performed as standard of care either at time of Hepatic trans-arterial embolization (TAE) or within 4 months prior to TAE. TAE is a standard of care procedure. Within 8 weeks of TAE, patient will have a clinic visit which will include medical history, physical examination, vital signs, EKG (if one is not available), and ECOG assessment. Additionally a dedicated liver CT or MR will be obtained as well as standard of care labs. IMPACT blood test will be performed at the time of any of the standard of care labs. As IMPACT platform at MSKCC continually evolves to include more genes, we will use the platform available at the time of initiation of the protocol, therefore all patients will be subjected to the same platform. RNA-seq has been demonstrated to be superior in detecting low abundance transcripts, demonstrating a broader dynamic range, and detecting different isoforms and genetic variants. | Procedure: Hepatic trans-arterial embolization (TAE)<br> <br> Device: MRI/CT scan<br> <br> Procedure: biopsy<br> <br> Other: blood draw<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response | Response will be categorized using standard mRECIST criteria. Tumor response will be catalogued as follows: Complete Response (CR): Disappearance of any intratumoral arterial enhancement in all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions. Stable Disease (SD): Any cases that do not qualify for either partial response or progressive disease. Progressive Disease (PD): An increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum of the of viable (enhancing) target lesions recorded since treatment started. | within 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MOLECULAR PREDICTORS, Hepatic trans-arterial embolization (TAE), 16-385