CT Perfusion Changes in GI Cancer During Adenosine Vasodilation Test
Abdominal Tissue Perfusion Changes in Esophageal and Gastric Cancer During Adenosine Vasodilation Measured With Computed Tomography (CT) Perfusion
1 other identifier
observational
15
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 20, 2014
CompletedFirst Posted
Study publicly available on registry
February 28, 2014
CompletedFebruary 28, 2014
February 1, 2014
10 months
February 20, 2014
February 26, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change in arterial flow during adenosine vasodilation test (CT perfusion parameter)
0 min and 15 min
Secondary Outcomes (5)
Change in Blood pressure during adenosine vasodilation test
0 min and 15 min
Change in Heart rate during adenosine vasodilation test
0 min and 15 min
Change in Area under arterial input curve during adenosine vasodilation test
0 min and 15 min
Change in Blood volume (CT perfusion parameter) during adenosine vasodilation test
0 min and 15 min
Change in Permeability (CT perfusion parameter) during adenosine vasodilation test.
0 min and 15 min
Study Arms (2)
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.
Eligibility Criteria
Patients with biopsy proven tumors in esophagus or stomach
You may qualify if:
- Tumour larger than 1.5 cm on diagnostic CT
- Normal serum creatinine
- Age above 18
- Informed written and oral consent.
You may not qualify if:
- Contrast allergy or contrast induced nephropathy
- BMI \> 40
- Asthma or Chronic Obstructive Lung Disease
- Heart failure (NYHA III+)
- Heart conduction disorder
- Atrial fibrillation
- nd/3rd Heart block
- Long QT syndrome
- Wolf Parkinson White Syndrome
- Moderate / severe aortic stenosis
- Haemodynamic contraindications for adenosine, systolic pressure below 90
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rigshospitalet
Copenhagen, 2100, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin L Hansen, MD
Rigshospitalet, Denmark
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
February 20, 2014
First Posted
February 28, 2014
Study Start
October 1, 2012
Primary Completion
August 1, 2013
Study Completion
December 1, 2013
Last Updated
February 28, 2014
Record last verified: 2014-02