NCT02074124

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 28, 2014

Completed
Last Updated

February 28, 2014

Status Verified

February 1, 2014

Enrollment Period

10 months

First QC Date

February 20, 2014

Last Update Submit

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

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Conditions

Esophageal NeoplasmsStomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Martin L Hansen, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

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

Locations