Prospective Tumor Response Evaluation

Study Overview
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Brief Summary
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The purpose of this study is to determine if MRI imaging can detect genetic, proteomic, and metabolomic characteristics of liver tumors. The study also aims to determine if these imaging characteristics are correlated with clinical outcomes.

Detailed Description
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For each treatment arm, pre-procedural MRI and post procedural MRI will be obtained. Pre-procedural biopsies will be obtained, if possible. Pretreatment genetic expression, proteomic, or metabolomic patterns from the tumor samples will be assessed. Imaging characteristics from tumors will be extracted using automated software-the study will apply a computational analysis system with the capability to extract and analyze imaging characteristics and correlate them to genetic expression, proteomic, and metabolomic tumor characteristics. Imaging findings will be correlated to clinical outcomes and genetic, proteomic, and metabolomic findings to determine association. Imaging findings and genomic, proteomic, and metabolomic tumor characteristics will be correlated to clinical outcomes (time to recurrence, overall survival, 3-month, 6-month, and 1-year survival).

Official Title
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Prospective Evaluation of Tumor Response to Cancer Treatment Therapies

Conditions
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Hepatocellular Cancer, Metastatic Liver Cancer

Intervention / Treatment
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* Procedure: TACE
* Procedure: Y-90
* Procedure: MWA
* Procedure: IRE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis or suspicion of primary or metastatic liver cancer deemed eligible for TACE, Y-90, percutaneous ablation, and /or electroporation. Exclusion Criteria: Any reason MRI cannot be obtained.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Transcatheter Chemoembolization or TACE<br>A technique called transcatheter chemoembolization (TACE) is used for some patients with liver cancer that cannot be treated surgically. The procedure is a way of delivering cancer treatment directly to a tumor through minimally-invasive means. | Procedure: TACE<br>* Procedure for giving chemotherapy directly to tumor cells.<br>* Other names: Transcatheter arterial chemoembolization;|
| Yittrium 90 or Y-90<br>Radioembolization is a minimally invasive procedure that combines embolization and radiation therapy to treat liver cancer. Tiny glass or resin beads filled with the radioactive isotope yttrium Y-90 are placed inside the blood vessels that feed a tumor. This blocks the supply of blood to the cancer cells and delivers a high dose of radiation to the tumor while sparing normal tissue. | Procedure: Y-90<br>* Using a combination of radiation and chemotherapy directly on the tumor cells to cause cell death.<br>* Other names: Yittrium 90;|
| Microwave Ablation or MWA<br>Microwave ablation (MWA), destroys liver tumors using heat generated by microwave energy. A CT scan or ultrasonic guidance is used to pinpoint the exact location of the tumor. A thin antenna, which emits microwaves, is then inserted into the tumor. The probe produces intense heat that ablates (destroys) tumor tissue, often within 10 minutes. | Procedure: MWA<br>* Using heat to kill tumor cells.<br>* Other names: Microwave Ablation;|
| electroporation<br>Irreversible electroporation (IRE) is a nonthermal method of destroying the cell. A cell is subjected to a powerful electrical field using high-voltage direct current (up to 3 kV); this creates multiple holes in the cell membrane and irreversibly damages the cell's homeostasis mechanism, leading to instant cell death. | Procedure: IRE<br>* Using energy to disrupt tumor cell activity, thereby causing cellular death.<br>* Other names: Irreversible Electroporation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression | Time from initial treatment to progression as defined by RECIST criteria. | 1 month to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 year survival | Number of patients alive 1 year after treatment | 1 year |