Prospective Tumor Response Evaluation

NCT ID: NCT02787954

Last Updated: 2018-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-04-30

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).

Conditions

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Hepatocellular Cancer Metastatic Liver Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

TACE

Intervention Type PROCEDURE

Procedure for giving chemotherapy directly to tumor cells.

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.

Y-90

Intervention Type PROCEDURE

Using a combination of radiation and chemotherapy directly on the tumor cells to cause cell death.

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.

MWA

Intervention Type PROCEDURE

Using heat to kill tumor cells.

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.

IRE

Intervention Type PROCEDURE

Using energy to disrupt tumor cell activity, thereby causing cellular death.

Interventions

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TACE

Procedure for giving chemotherapy directly to tumor cells.

Intervention Type PROCEDURE

Y-90

Using a combination of radiation and chemotherapy directly on the tumor cells to cause cell death.

Intervention Type PROCEDURE

MWA

Using heat to kill tumor cells.

Intervention Type PROCEDURE

IRE

Using energy to disrupt tumor cell activity, thereby causing cellular death.

Intervention Type PROCEDURE

Other Intervention Names

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Transcatheter arterial chemoembolization Yittrium 90 Microwave Ablation Irreversible Electroporation

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Derek L West, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Healtlh Science Center at Houston

Locations

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University of Texas Health Science Center Houston

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22353262 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24077865 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24945002 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19048335 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20109351 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23428860 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24029645 (View on PubMed)

Other Identifiers

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HSC-MS-14-0761

Identifier Type: -

Identifier Source: org_study_id

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