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OpenTrials
Completed

NCT Number: NCT02472249

Pharmacological Manipulation of Intrahepatic Arterial Blood Flow in HCC

Dr Rajan is investigating a new method to improve local treatment of liver cancer. There is evidence that a drug, norepinephrine (NE), has the ability to shrink down normal liver blood vessels, but leave tumor vessels wide open. In patients with primary liver cancer, NE will be injected directly in the artery that nourishes the liver and the tumor. Real time blood flow will be measured using an advanced CT scanner to demonstrate the NE effect on blood vessels. If Dr Rajan's hypothesis is confirmed, this drug has great potential to benefit patients during local delivery of chemotherapy in the liver artery, diverting it away from normal liver and towards the tumor, resulting in less complications and improved tumor kill.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

About this study

This study aims to evaluate the blood flow modifications in liver following injection of norepinephrine in the hepatic artery. These blood flow variations have never been dynamically evaluated before. If indeed blood flow modulation in liver is favorable, the use of norepinephrine prior to localized chemotherapy has great potential to enhance treatment and diminish side effects. Patients with hepatocellular carcinoma, a primary liver cancer, will be selected for this study. Included patients will have a trans-arterial chemoembolization (TACE) procedure scheduled as treatment for their cancer. During their procedure, they will be brought to an advanced CT-scanner. CT perfusion imaging will be performed prior, and after the injection of the study drug in the liver artery. Patient's treatment will then be completed. Perfusion color maps will illustrate blood flow. Perfusion values will be correlated to see how the drug modulates blood flow in tumor and in normal liver.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Biopsy proven HCC< or confident diagnosis of HCC on multi-phasic CT or MRI
  • Selection criteria for chemoembolization must be met, including adequate coagulation profile and serum creatinine, patent portal vein, no severe contrast allergy, cirrhosis Child A or B.
  • 5 or less untreated nodular hepatic tumors within the lobe to undergo chemoembolization. Larger nodule must be equal or over 3 cm.
  • Patient must be able to provide written, informed consent.

Exclusion criteria

  • Symptoms or history of ischemic cardiac disease or arrhythmia
  • Uncontrolled hypertension
  • Pregnancy or desire to get pregnant
  • Severe COPD, FEVS lower than 30%
  • Prior documented hypersensitivity to norepinephrine
  • Patients receiving MAO inhibitors, or anti-depressants of the triptyline or imipramine types

Treatment and study plan

CT Perfusion

Radiation

Two dynamic CT perfusion acquisitions of the whole liver will be performed with a 320-detectors CT, prior and after to the norepinephrine injection.

Norepinephrine intra-arteriel/hepatic

Drug

A small dose (24 ug) of norepinephrine will be injected in the hepatic artery over 10 seconds. The half-life of the drug is 90 seconds..

Primary outcomes

  1. Liver blood flow

    Time frame: 1 minute following injection

    Liver blood flow as measured with CT perfusion

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Hepatic Arterial Blood Flow Modulation in Patients With Hepatocellular Carcinoma: Influence of Intra-arterial Norepinephrine Assessed With CT Perfusion

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 15, 2015
Registry last updated
Apr 28, 2021

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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