CT Perfusion Changes in GI Cancer During Adenosine Vasodilation Test

February 26, 2014 updated by: Martin Lundsgaard Hansen, University of Copenhagen

Abdominal Tissue Perfusion Changes in Esophageal and Gastric Cancer During Adenosine Vasodilation Measured With Computed Tomography (CT) Perfusion

The aim of this study was to investigate changes in abdominal tissue perfusion during adenosine vasodilation. Our hypotheses were that CT perfusion measurements are altered by changes in the circulatory system mediated by adenosine, and a more differentiated assessment of the circulatory capacity of abdominal tumours could be achieved by sequential rest and adenosine vasodilation CT perfusion measurements.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Denmark
- - Copenhagen, Denmark, 2100
    - Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with biopsy proven tumors in esophagus or stomach

Description

Inclusion Criteria:

Tumour larger than 1.5 cm on diagnostic CT
Normal serum creatinine
Age above 18
Informed written and oral consent.

Exclusion Criteria:

Contrast allergy or contrast induced nephropathy
BMI > 40
Asthma or Chronic Obstructive Lung Disease
Heart failure (NYHA III+)
Heart conduction disorder
Atrial fibrillation
2nd/3rd Heart block
Long QT syndrome
Wolf Parkinson White Syndrome
Moderate / severe aortic stenosis
Haemodynamic contraindications for adenosine, systolic pressure below 90

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Adenosine Vasodilation test Group scanned with CT perfusion during adenosine vasodilation test.
Reference group Group scanned twice without adenosine vasodilation test for a reference. No randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in arterial flow during adenosine vasodilation test (CT perfusion parameter) Time Frame: 0 min and 15 min	0 min and 15 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Blood pressure during adenosine vasodilation test Time Frame: 0 min and 15 min		0 min and 15 min
Change in Heart rate during adenosine vasodilation test Time Frame: 0 min and 15 min		0 min and 15 min
Change in Area under arterial input curve during adenosine vasodilation test Time Frame: 0 min and 15 min	Area Under Curve (AUC) is correlated to cardiac output	0 min and 15 min
Change in Blood volume (CT perfusion parameter) during adenosine vasodilation test Time Frame: 0 min and 15 min		0 min and 15 min
Change in Permeability (CT perfusion parameter) during adenosine vasodilation test. Time Frame: 0 min and 15 min		0 min and 15 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Investigators

Principal Investigator: Martin L Hansen, MD, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 20, 2014

First Submitted That Met QC Criteria

February 26, 2014

First Posted (Estimate)

February 28, 2014

Study Record Updates

Last Update Posted (Estimate)