CT Perfusion Changes in GI Cancer During Adenosine Vasodi... | NCT02074124

Studies
CT Perfusion Changes in GI Cancer During Adenosine Vasodilation Test

NCT02074124

Sponsor

University of Copenhagen

Status

Completed

Last Update Posted

Feb 28, 2014Estimated

Enrollment

15Actual

Phase

Not provided

Conditions

Esophageal Cancer
Gastric Cancer

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
H-3-2012-067	Other Identifier	Committees on Biomedical Research for the Capital Region of Denmark

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Aug 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Feb 20, 2014

First Submission Date that Met QC Criteria

Feb 26, 2014

First Posted Date

Feb 28, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2014

Last Update Posted Date

Feb 28, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with biopsy proven tumors in esophagus or stomach

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martin L Hansen, MD	Rigshospitalet, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet		Copenhagen		2100	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D004938	Esophageal Neoplasms
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided