Prospective Tumor Response Evaluation

Hepatocellular Cancer Clinical Trial

— Liver  

Official title:

Prospective Evaluation of Tumor Response to Cancer Treatment Therapies

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02787954
• Other study ID #: HSC-MS-14-0761
• Status: Terminated
• Start date: January 2016
• Est. completion date: April 2017

Study information

• Verified date: October 2018
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Cancer
• Liver Neoplasms
• Metastatic Liver Cancer

Intervention

Procedure:
• TACE
Procedure for giving chemotherapy directly to tumor cells.
• Y-90
Using a combination of radiation and chemotherapy directly on the tumor cells to cause cell death.
• MWA
Using heat to kill tumor cells.
• IRE
Using energy to disrupt tumor cell activity, thereby causing cellular death.

Locations

Country	Name	City	State
United States	University of Texas Health Science Center Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression	Time from initial treatment to progression as defined by RECIST criteria.	1 month to 3 years
Secondary	1 year survival	Number of patients alive 1 year after treatment	1 year