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Completed

NCT Number: NCT02093104

TACE Study-Liver Embolization Perfusion (VGH Radiology LIU)

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vancouver General Hospital

Vancouver, British Columbia, V5Z1M9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • OR radiologic evidence of liver metastatic disease
  • Amenable to embolization or ablation as adjuvant, neoadjuvant or definitive (curative or palliative) therapy.
  • Adult > 19 years old and estimated life expectancy over 3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status under or equals 1
  • 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
  • Adequate renal function; serum creatinine under 150μmol/L
  • 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
  • Liver cirrhosis Child Pugh A - B7
  • Ability to provide written informed consent

Exclusion criteria

  • Advanced liver disease with Child-Pugh score over 7 or active gastrointestinal bleeding or encephalopathy or ascites refractory to diuretic therapy
  • Women who are pregnant or breast feeding
  • Allergy to contrast media
  • 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.
  • Psychiatric or other disorder likely to impact on informed consent
  • Patient unable and/or unwilling to comply with treatment and study instructions

Treatment and study plan

Primary outcomes

  1. Liver Tumour Perfusion using CT & C-arm systems in 40 patients at VGH over a 3 month period

    Time frame: 3 months

    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)

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study 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"

Acronym: TACE

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 20, 2014
Registry last updated
May 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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