Prospective Tumor Response Evaluation (Liver)
October 16, 2018 updated by: The University of Texas Health Science Center, Houston
Prospective Evaluation of Tumor Response to Cancer Treatment Therapies
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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).
Study Type
Observational
Enrollment (Actual)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Houston, Texas, United States, 77030
- University of Texas Health Science Center Houston
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Transcatheter Chemoembolization or TACE
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.
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Procedure for giving chemotherapy directly to tumor cells.
Other Names:
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Yittrium 90 or Y-90
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.
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Using a combination of radiation and chemotherapy directly on the tumor cells to cause cell death.
Other Names:
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Microwave Ablation or MWA
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.
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Using heat to kill tumor cells.
Other Names:
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electroporation
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.
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Using energy to disrupt tumor cell activity, thereby causing cellular death.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Time to progression
Time Frame: 1 month to 3 years
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Time from initial treatment to progression as defined by RECIST criteria.
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1 month to 3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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1 year survival
Time Frame: 1 year
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Number of patients alive 1 year after treatment
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Derek L West, MD, University of Texas Healtlh Science Center at Houston
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Forner A, Llovet JM, Bruix J. Hepatocellular carcinoma. Lancet. 2012 Mar 31;379(9822):1245-55. doi: 10.1016/S0140-6736(11)61347-0. Epub 2012 Feb 20.
- Gu L, Liu H, Fan L, Lv Y, Cui Z, Luo Y, Liu Y, Li G, Li C, Ma J. Treatment outcomes of transcatheter arterial chemoembolization combined with local ablative therapy versus monotherapy in hepatocellular carcinoma: a meta-analysis. J Cancer Res Clin Oncol. 2014 Feb;140(2):199-210. doi: 10.1007/s00432-013-1528-8.
- Raoul JL, Gilabert M, Piana G. How to define transarterial chemoembolization failure or refractoriness: a European perspective. Liver Cancer. 2014 May;3(2):119-24. doi: 10.1159/000343867.
- Assumpcao L, Choti M, Pawlik TM, Gecshwind JF, Kamel IR. Functional MR imaging as a new paradigm for image guidance. Abdom Imaging. 2009 Nov;34(6):675-85. doi: 10.1007/s00261-008-9481-8. Epub 2008 Dec 2.
- Bian DJ, Xiao EH, Hu DX, Chen XY, Situ WJ, Yuan SW, Sun JL, Yang LP. Magnetic resonance spectroscopy on hepatocellular carcinoma after transcatheter arterial chemoembolization. Chin J Cancer. 2010 Feb;29(2):198-201.
- Minami Y, Kudo M. Therapeutic response assessment of transcatheter arterial chemoembolization for hepatocellular carcinoma: ultrasonography, CT and MR imaging. Oncology. 2013;84 Suppl 1:58-63. doi: 10.1159/000345891. Epub 2013 Feb 20.
- Karlo CA, Di Paolo PL, Chaim J, Hakimi AA, Ostrovnaya I, Russo P, Hricak H, Motzer R, Hsieh JJ, Akin O. Radiogenomics of clear cell renal cell carcinoma: associations between CT imaging features and mutations. Radiology. 2014 Feb;270(2):464-71. doi: 10.1148/radiol.13130663. Epub 2013 Oct 28.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
April 1, 2017
Study Completion (Actual)
April 1, 2017
Study Registration Dates
First Submitted
May 26, 2016
First Submitted That Met QC Criteria
May 26, 2016
First Posted (Estimate)
June 1, 2016
Study Record Updates
Last Update Posted (Actual)
October 18, 2018
Last Update Submitted That Met QC Criteria
October 16, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-MS-14-0761
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.