Pharmacological Manipulation of Intrahepatic Arterial Blood Flow in HCC

NCT02472249 | Completed Phase 4

• 1 other identifier: 14-8122-C
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

TACE; CT perfusion; Liver blood flow

Outcome Measures

Primary Outcomes (1)

• Liver blood flow

  Liver blood flow as measured with CT perfusion

  1 minute following injection

Study Arms (1)

Norepinephrine intra-arteriel/hepatic

EXPERIMENTAL

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; Drug: Norepinephrine intra-arteriel/hepatic

Interventions

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

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..

Norepinephrine intra-arteriel/hepatic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Cytidine Triphosphate

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Dheeraj Rajan, MD FRCPC

  University Health Network/Mount Sinai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: June 15, 2015
• Study Start: January 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

CA (1)