Pancreas CancerNCT00259532
Three New Methods for Diagnosing Pancreas Cancer
A study testing Ultrasound and contrast agent in people with Pancreas Cancer, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The purpose of this project is to evaluate and compare three new methods for diagnosis, staging, operability evaluation and treatment control of pancreas cancer. The investigators use contrast-enhanced ultrasound combined with the gastrointestinal hormones Secretin and Cholecystokinin, which triggers the enzyme… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- Ultrasound and contrast agent
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2005to Jan 2009
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- suspicion of cancer of the pancreas
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital
Copenhagen, 2100
Hanne S Grossjohann, MD, +45 35453419, hannesonder@dadlnet.dk
Hanne S Grossjohann, MD
About this study
Official title: Ultrasound With Contrast Agent, 64-Slice-CT and Tumormarkers for Diagnosing, Evaluation of Operability and Treatment Control of Pancreas Cancer
The purpose of this project is to evaluate and compare three new methods for diagnosis, staging, operability evaluation and treatment control of pancreas cancer. The investigators use contrast-enhanced ultrasound combined with the gastrointestinal hormones Secretin and Cholecystokinin, which triggers the enzyme production of pancreas. The hormones induce an increased metabolism and thus an increased blood flow through healthy pancreas tissue, however, not in tumor tissue. The investigators hope to be able to use this effect diagnostically. The patients included will also have a 64-slice-CT in order to evaluate, if an increased diagnostic safety can be reached compared to an older CT scanning method. All patients will also be examined for the tumor marker CA 19-9. Further, the investigators will examine if contrast-enhanced ultrasound can contribute with information in treatment control after either surgery or medical treatment.
- Conditions
- Pancreas Cancer
- Being tested
- Ultrasound and contrast agent
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound and contrast agentProcedure or surgery
contrast-enhanced ultrasound combined with the gastrointestinal hormones Secretin and Cholecystokinin, which triggers the enzyme production of pancreas
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2005 (estimated)
- Study startFeb 2005
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Michael B Nielsen, DMSc, Principal investigator, Department of Radiology, Section of Ultrasound
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259532
- Sponsor's protocol ID
- (KF) 01 268342
- Status last verified
- Feb 2009
- First submitted
- 25 Nov 2005
- Last updated
- 26 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound With Contrast Agent, 64-Slice-CT and Tumormarkers for Diagnosing, Evaluation of Operability and Treatment Control of Pancreas Cancer
- ClinicalTrials.gov ID
- NCT00259532
- Acronym / sponsor ID
- (KF) 01 268342
- Conditions
- Pancreas Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Feb 2005
- Study completion
- Jan 2009
- First posted
- 29 Nov 2005 (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 purpose of this project is to evaluate and compare three new methods for diagnosis, staging, operability evaluation and treatment control of pancreas cancer. The investigators use contrast-enhanced ultrasound combined with the gastrointestinal hormones Secretin and Cholecystokinin, which triggers the enzyme production of pancreas. The hormones induce an increased metabolism and thus an increased blood flow through healthy pancreas tissue, however, not in tumor tissue. The investigators hope to be able to use this effect diagnostically. The patients included will also have a 64-slice-CT in order to evaluate, if an increased diagnostic safety can be reached compared to an older CT scanning method. All patients will also be examined for the tumor marker CA 19-9. Further, the investigators will examine if contrast-enhanced ultrasound can contribute with information in treatment control after either surgery or medical treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- suspicion of cancer of the pancreas
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound and contrast agentcontrast-enhanced ultrasound combined with the gastrointestinal hormones Secretin and Cholecystokinin, which triggers the enzyme production of pancreas | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2009.
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Pancreas Cancer
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.
Michael B Nielsen, DMSc principal investigator
Department of Radiology, Section of Ultrasound
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound and contrast agent in people with Pancreas 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 1 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 26 Feb 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanne S Grossjohann, MD (+45 35453419, hannesonder@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 26 Feb 2009.