Clinical trial NCT02787954: Prospective Tumor Response Evaluation
Official title: Prospective Evaluation of Tumor Response to Cancer Treatment Therapies
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatocellular Cancer
Metastatic Liver Cancer
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2016-06-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary or metastatic liver cancer, who are deemed candidates for TACE, electroporation, MWA, or Y90 will be enrolled. The patients will be recruited from medical oncology, surgical oncology, gastroenterology, and transplant surgery services.

Brief summary: 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: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Time to progression
timeFrame: 1 month to 3 years
Secondary outcomes:
measure: 1 year survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center Houston
state: Texas
Study officials:
affiliation: University of Texas Healtlh Science Center at Houston
name: Derek L West, MD
role: PRINCIPAL_INVESTIGATOR
References:
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