Esophageal CancerNCT02074124
CT Perfusion Changes in GI Cancer During Adenosine Vasodilation Test
An observational study of Esophageal Cancer and Gastric Cancer, run by University of Copenhagen at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Esophageal Cancer, Gastric Cancer
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with biopsy proven tumors in esophagus or stomach
Who may be able to join
- Tumour larger than 1.5 cm on diagnostic CT
- Normal serum creatinine
- Age above 18
- Informed written and oral consent.
Who cannot join
- Contrast allergy or contrast induced nephropathy
- BMI > 40
- Asthma or Chronic Obstructive Lung Disease
- Heart failure (NYHA III+)
- Heart conduction disorder
- Atrial fibrillation
Show all 11Show fewer
- 2nd/3rd Heart block
- Long QT syndrome
- Wolf Parkinson White Syndrome
- Moderate / severe aortic stenosis
- Haemodynamic contraindications for adenosine, systolic pressure below 90
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Esophageal Cancer, Gastric Cancer
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in arterial flow during adenosine vasodilation test (CT perfusion parameter)
Measured: 0 min and 15 min
Secondary outcomes (5)
Change in Blood pressure during adenosine vasodilation test
Measured: 0 min and 15 min
Change in Heart rate during adenosine vasodilation test
Measured: 0 min and 15 min
Change in Area under arterial input curve during adenosine vasodilation test
Area Under Curve (AUC) is correlated to cardiac output
Measured: 0 min and 15 min
Change in Blood volume (CT perfusion parameter) during adenosine vasodilation test
Measured: 0 min and 15 min
Change in Permeability (CT perfusion parameter) during adenosine vasodilation test.
Measured: 0 min and 15 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startOct 2012
- Primary completionAug 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Lundsgaard Hansen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Martin L Hansen, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074124
- Sponsor's protocol ID
- H-3-2012-067
- Other IDs
- H-3-2012-067
- Status last verified
- Feb 2014
- First submitted
- 20 Feb 2014
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Tissue Perfusion Changes in Esophageal and Gastric Cancer During Adenosine Vasodilation Measured With Computed Tomography (CT) Perfusion
- ClinicalTrials.gov ID
- NCT02074124
- Acronym / sponsor ID
- H-3-2012-067
- Conditions
- Esophageal Cancer, Gastric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 28 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with biopsy proven tumors in esophagus or stomach
Key inclusion criteria (4 listed)
- Tumour larger than 1.5 cm on diagnostic CT
- Normal serum creatinine
- Age above 18
- Informed written and oral consent.
Key exclusion criteria (11 listed)
- Contrast allergy or contrast induced nephropathy
- BMI > 40
- Asthma or Chronic Obstructive Lung Disease
- Heart failure (NYHA III+)
- Heart conduction disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in arterial flow during adenosine vasodilation test (CT perfusion parameter)
Time frame: 0 min and 15 min
5 secondary outcomes
Change in Blood pressure during adenosine vasodilation test
Time frame: 0 min and 15 min
Change in Heart rate during adenosine vasodilation test
Time frame: 0 min and 15 min
Change in Area under arterial input curve during adenosine vasodilation test
Time frame: 0 min and 15 min
Change in Blood volume (CT perfusion parameter) during adenosine vasodilation test
Time frame: 0 min and 15 min
Change in Permeability (CT perfusion parameter) during adenosine vasodilation test.
Time frame: 0 min and 15 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin L Hansen, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer and Gastric Cancer, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in arterial flow during adenosine vasodilation test (CT perfusion parameter) (time frame: 0 min and 15 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2014.