Clinical trial NCT02093104: TACE Study-Liver Embolization Perfusion (VGH Radiology LIU)
Official title: 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"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unresectable Hepatocellular Carcinoma
Undergoing Chemoembolization and Radioembolization
Keywords: unresectable hepatocellular carcinoma
(undergoing chemoembolization and radioembolization)
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2014-03-20
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with unresectable hepatocellular carcinoma undergoing chemoembolization and radioembolization

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Liver Tumour Perfusion using CT & C-arm systems in 40 patients at VGH over a 3 month period
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: UBC/VCHA/VGH
name: David MT Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: