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Pharmacological Manipulation of Intrahepatic Arterial Blood Flow in HCC

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ClinicalTrials.gov Identifier: NCT02472249
Recruitment Status : Recruiting
First Posted : June 15, 2015
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Radiation: CT perfusion Drug: Norepinephrine intra-arteriel/hepatic Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Hepatic Arterial Blood Flow Modulation in Patients With Hepatocellular Carcinoma: Influence of Intra-arterial Norepinephrine Assessed With CT Perfusion
Study Start Date : January 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Norepinephrine intra-arteriel/hepatic
This is the only arm of this study. These patients will receive 24 micrograms of norepinephrine in the hepatic artery with subsequent CT perfusion imaging to evaluate liver blood flow.
Radiation: CT perfusion
Two dynamic CT perfusion acquisitions of the whole liver will be performed with a 320-detectors CT, prior and after to the norepinephrine injection.

Drug: Norepinephrine intra-arteriel/hepatic
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 Outcome Measures :
  1. Liver blood flow [ Time Frame: 1 minute following injection ]
    Liver blood flow as measured with CT perfusion



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02472249


Contacts
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Contact: Maxime Noel-Lamy, MD FRCPC 416-946-4501 ext 5054 maxime.noel-lamy@uhn.ca

Locations
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Canada, Ontario
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2N2
Contact: Maxime Noel-Lamy, MD FRCPC    416-946-4501 ext 5054    maxime.noel-lamy@uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Dheeraj Rajan, MD FRCPC University Health Network/Mount Sinai Hospital

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02472249     History of Changes
Other Study ID Numbers: 14-8122-C
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019

Keywords provided by University Health Network, Toronto:
TACE
CT perfusion
Liver blood flow

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Norepinephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents