TACE Study-Liver Embolization Perfusion (VGH Radiology LIU) (TACE)

Utilizing Intraprocedural Flow and Perfusion Dynamics as a Predictor of Response in Patients With Unresectable Hepatocellular Carcinoma Undergoing Chemoembolization and Radioembolization (Y90) "Liver Embolization Perfusion TACE Study (Version 1.0) EPTS 2013-1.0"

The purpose of this research study is to evaluate the quantitative information of utilizing C-arm systems in liver tumor care in hopes this potential clinical combination of imaging could aid in diagnosis and evaluation of tumor therapy.

Study Overview

• Status: Completed
• Conditions: Unresectable Hepatocellular Carcinoma; Undergoing Chemoembolization and Radioembolization

Detailed Description

Blood flow imaging for liver tumors is normally carried out using clinical Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) systems prior to going to the cath lab. This study aims to determine if measuring flow using a C-arm system and/or CT perfusion can be used to improve diagnosis and evaluation of liver tumors.

The major difference between C-arm CT systems and clinical CT systems is the difference in imaging speed. We have developed a new approach that should allow us to overcome this speed limitation. The major difference between conventional CT versus CT perfusion is the obtaining of an extra series of images. CT perfusion results in an increase in the amount of radiation exposure during the CT scan that measures the blood flow of the targeted tumor; however, CT perfusion is much faster than conventional CT.

Prospective participants are being invited to the study because part of the treatment towards the tumour therapy involves obtaining an angiogram.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z1M9
      • Vancouver General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with unresectable hepatocellular carcinoma undergoing chemoembolization and radioembolization

Description

Inclusion Criteria:

1. Histological or cytological diagnosis or meet the AASLD criteria for diagnosis of hepatocellular carcinoma (HCC) and at least one uni-dimensional lesion measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria by CT-scan
2. OR radiologic evidence of liver metastatic disease
3. Amenable to embolization or ablation as adjuvant, neoadjuvant or definitive (curative or palliative) therapy.
4. Adult > 19 years old and estimated life expectancy over 3 months
5. Eastern Cooperative Oncology Group (ECOG) performance status under or equals 1
6. Adequate haematological function: Hb over or equals 9g/100mL, absolute neutrophil count over or equals 1 500/mm3, platelet count over or equals 50 000/mm3
7. Adequate renal function; serum creatinine under 150μmol/L
8. Bilirubin under or equals 50 µmol/L, Aspartate aminotransferase (AST) or ALT uner or equals 5 x upper limit of normal (ULN), international normalized ratio (INR) under or equals 1.5
9. Liver cirrhosis Child Pugh A - B7
10. Ability to provide written informed consent

Exclusion Criteria:

1. Advanced liver disease with Child-Pugh score over 7 or active gastrointestinal bleeding or encephalopathy or ascites refractory to diuretic therapy
2. Women who are pregnant or breast feeding
3. Allergy to contrast media
4. Contraindication to hepatic artery catheterisation, such as severe peripheral vascular disease precluding catheterisation OR contraindication to locally curative ablation due to size, location or shape.
5. Psychiatric or other disorder likely to impact on informed consent
6. Patient unable and/or unwilling to comply with treatment and study instructions

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver Tumour Perfusion using CT & C-arm systems in 40 patients at VGH over a 3 month period	The purpose of this protocol is to study the potential predictive and prognostic value of tumor perfusion assessment utilizing computed tomography and C-arm systems in the treatment of liver tumors. Observational nature of study; post hoc analysis precludes determination of primary endpoint. 3 month follow-up CT scans as per protocol involving standard of care 4 phase CT scan in addition to perfusion CT Utilizing intraprocedural flow and perfusion dynamics as a predictor of response in 40 patients with unresectable hepatocellular carcinoma undergoing intraprocedural flow and perfusion dynamics as a predictor of response in chemoembolization and radioembolization (Y90)	3 months

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: David MT Liu, MD, UBC/VCHA/VGH

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: March 10, 2014
• First Submitted That Met QC Criteria: March 17, 2014
• First Posted (Estimate): March 20, 2014

Study Record Updates

• Last Update Posted (Actual): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: unresectable hepatocellular carcinoma; (undergoing chemoembolization and radioembolization)
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: H12-03704; SIEMENS Canada/USA (Other Identifier: UBC CREB)