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Prospective Tumor Response Evaluation (Liver)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02787954
Recruitment Status : Terminated (PI transferred to another institution and did not take this study with him.)
First Posted : June 1, 2016
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment
Hepatocellular Cancer Metastatic Liver Cancer Procedure: TACE Procedure: Y-90 Procedure: MWA Procedure: IRE

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).

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Study Type : Observational [Patient Registry]
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Prospective Evaluation of Tumor Response to Cancer Treatment Therapies
Actual Study Start Date : January 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

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.
Procedure: TACE
Procedure for giving chemotherapy directly to tumor cells.
Other Name: Transcatheter arterial chemoembolization

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.
Procedure: Y-90
Using a combination of radiation and chemotherapy directly on the tumor cells to cause cell death.
Other Name: Yittrium 90

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.
Procedure: MWA
Using heat to kill tumor cells.
Other Name: Microwave Ablation

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.
Procedure: IRE
Using energy to disrupt tumor cell activity, thereby causing cellular death.
Other Name: Irreversible Electroporation




Primary Outcome Measures :
  1. Time to progression [ Time Frame: 1 month to 3 years ]
    Time from initial treatment to progression as defined by RECIST criteria.


Secondary Outcome Measures :
  1. 1 year survival [ Time Frame: 1 year ]
    Number of patients alive 1 year after treatment


Biospecimen Retention:   Samples With DNA
Biopsy liver tumor samples and blood tumor samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787954


Locations
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United States, Texas
University of Texas Health Science Center Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Derek L West, MD University of Texas Healtlh Science Center at Houston
Additional Information:

Publications:

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Responsible Party: The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02787954    
Other Study ID Numbers: HSC-MS-14-0761
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Liver Neoplasms
Carcinoma, Hepatocellular
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type