CT Perfusion Changes in GI Cancer During Adenosine Vasodilation Test

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02074124
• Other study ID #: H-3-2012-067
• Secondary ID: H-3-2012-067
• Status: Completed
• Phase: N/A
• First received: February 20, 2014
• Last updated: February 26, 2014
• Start date: October 2012
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in arterial flow during adenosine vasodilation test (CT perfusion parameter)		0 min and 15 min	No
Secondary	Change in Blood pressure during adenosine vasodilation test		0 min and 15 min	No
Secondary	Change in Heart rate during adenosine vasodilation test		0 min and 15 min	No
Secondary	Change in Area under arterial input curve during adenosine vasodilation test	Area Under Curve (AUC) is correlated to cardiac output	0 min and 15 min	No
Secondary	Change in Blood volume (CT perfusion parameter) during adenosine vasodilation test		0 min and 15 min	No
Secondary	Change in Permeability (CT perfusion parameter) during adenosine vasodilation test.		0 min and 15 min	No