Clinical trial NCT02472249: Pharmacological Manipulation of Intrahepatic Arterial Blood Flow in HCC
Official title: Hepatic Arterial Blood Flow Modulation in Patients With Hepatocellular Carcinoma: Influence of Intra-arterial Norepinephrine Assessed With CT Perfusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatocellular Carcinoma
Keywords: TACE
CT perfusion
Liver blood flow
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2015-06-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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

Primary outcomes:
measure: Liver blood flow
timeFrame: 1 minute following injection
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network/Mount Sinai Hospital
name: Dheeraj Rajan, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: