Prospective Tumor Response Evaluation

NCT02787954 | Terminated

• 1 other identifier: HSC-MS-14-0761
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Cancer; Metastatic Liver Cancer

Outcome Measures

Primary Outcomes (1)

• Time to progression

  Time from initial treatment to progression as defined by RECIST criteria.

  1 month to 3 years

Secondary Outcomes (1)

• 1 year survival

  1 year

Study Arms (4)

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

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

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

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

Interventions

TACE PROCEDURE

Procedure for giving chemotherapy directly to tumor cells.

Also known as: Transcatheter arterial chemoembolization

Transcatheter Chemoembolization or TACE

Y-90 PROCEDURE

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

Also known as: Yittrium 90

Yittrium 90 or Y-90

MWA PROCEDURE

Using heat to kill tumor cells.

Also known as: Microwave Ablation

Microwave Ablation or MWA

IRE PROCEDURE

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

Also known as: Irreversible Electroporation

electroporation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Diagnosis or suspicion of primary or metastatic liver cancer deemed eligible for TACE, Y-90, percutaneous ablation, and /or electroporation.

You may not qualify if:

• Any reason MRI cannot be obtained.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

University of Texas Health Science Center Houston

Houston, Texas, 77030, United States

Location

Related Publications (7)

• 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.

  PMID: 22353262 BACKGROUND

• 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.

  PMID: 24077865 BACKGROUND

• 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.

  PMID: 24945002 BACKGROUND

• 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.

  PMID: 19048335 BACKGROUND

• 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.

  PMID: 20109351 BACKGROUND

• 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.

  PMID: 23428860 BACKGROUND

• 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.

  PMID: 24029645 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Biopsy liver tumor samples and blood tumor samples

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Yttrium-90; Electroporation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Officials

• Derek L West, MD

  University of Texas Healtlh Science Center at Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: June 1, 2016
• Study Start: January 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: October 18, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)