Crohn DiseaseKULTNCT01365767
Contrast Ultrasound of the Small Intestine in Patients With Crohns Disease
An observational study of Crohn Disease, run by Rune Wilkens at 2 sites in Denmark.
Trial summary
The purpose of this study is to determine how relevant dynamic ultrasound scans using contrast agents (SonoVue) is in the diagnosis of Crohns disease in the small bowel, compared to dynamic Magnetic Resonance Imaging (MRI) of the small bowel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- How many people
- 5 participants
- Where
- 2 sitesDenmark
- Study dates
- May 2011to Sep 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated on Regional Hospital of Silkeborg.
Who may be able to join
- Patients with known Crohns Disease
- 18 years old or older.
- Referred to a Magnetic Resonance Imaging scan of the small bowel
Who cannot join
- Contraindications to or not suitable of a Magnetic Resonance Imaging
- Liver transplant
- nursing og pregnancy
- Known Allergy of SonoVue
- Acute Myocardial infarction < 4 weeks
- Coronary angiography < 4 weeks
Show all 14Show fewer
- Electrocardiogram changes < 4 weeks
- frequent and repetitive angina pectoris symptoms within the last week.
- Heartfailure
- serious arrhythmia
- right to left heart shunt
- Very high pulmonary artery pressure
- uncontrolled hypertension
- Adult respiratory distress syndrome
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aarhus University Hospital
Aarhus, DK-8000
Medical department, Regional Hospital of Silkeborg
Silkeborg, DK-8600
About this study
Official title: Kontrast UltraLydsskanning af Tyndtarmen Hos Patienter Med Crohns Sygdom - et Pilotstudie. (Danish) Contrast Ultrasound of the Small Intestine in Patients With Crohns Disease - a Pilot Study (English)
The purpose of this study is to determine how relevant dynamic ultrasound scans using contrast agents (SonoVue) is in the diagnosis of Crohns disease in the small bowel, compared to dynamic Magnetic Resonance Imaging (MRI) of the small bowel.
Read the detailed description
Crohns disease (CD) is a lifelong chronic Inflammatory Bowel Disease (IBD) normally with an early debut. It requires continuous evaluation with either endoscopy, Magnetic Resonance Imaging (MRI), Computed Tomography (CT) or Wireless Capsule Endoscopy (WCE). These methods are either expensive, invasive or with uses radiation. Therefore UltraSound (US), as a cheap, fast and well tolerated examination of the small bowel are tested against the the validated MRI examination of the small bowel. Both examinations are using intra venous (i.v.) contrast agents. Obtained results are compared to disease activity.
Hypothesis is, that dynamic US is comparable to dynamic MRI and therefore should be the first examination of choice in evaluating patients with CD.
This study is a pilot study only.
- Conditions
- Crohn Disease
- Keywords
- Crohn disease, Ultrasonography, contrast enhanced, Elasticity Imaging Techniques, Small intestine, Magnetic Resonance Imaging, CDAI, Calprotectin, IBD, Sonography
- Medical subject headings
- Crohn Disease
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 |
|---|---|---|
| Crohn Disease | Patients with Crohns Disease referred to referred to a Magnetic Resonance Imaging Scan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between time-intensity curves of dynamic ultrasound and dynamic Magnetic Resonance Imaging
Time intesity curves are obtained using intra venous contrast agents during Magnetic Resonance Imaging scans and Ultrasound examination of the small bowel
Measured: up to 1 week
Secondary outcomes (5)
Correlation between elastography scans of Magnetic Resonance Imaging and Ultrasound of the small bowel
Measured: up to 1 week
Correlation between Doppler Score and Contrast Enhanced Ultrasound Score
Doppler score (Limberg score) and Contrast Enhanced Ultrasound score are obtained during the same scanning procedure
Measured: up to 1 week
Correlation between greatest bowel wall thickness and disease activity measured in Ultrasound and Magnetic Resonance Imaging
Measured: up to 1 week
Correlation between Ultrasound score and Faeces Calprotectin
Measured: up to 2 months
Correlation between Crohns disease activity index and Ultrasound score
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rune Wilkens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rune Wilkens, Regionshospitalet Silkeborg
- Investigators
- Henning Glerup, Study chair, Region Hospital of SilkeborgRune Wilkens, Principal investigator, Region Hospital of SilkeborgLars B. Hansen, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365767
- Sponsor's protocol ID
- HGRWLBKULT1
- Other IDs
- 2010-024528-12
- Acronym
- KULT
- Status last verified
- Jul 2013
- First submitted
- 27 May 2011
- Last updated
- 16 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kontrast UltraLydsskanning af Tyndtarmen Hos Patienter Med Crohns Sygdom - et Pilotstudie. (Danish) Contrast Ultrasound of the Small Intestine in Patients With Crohns Disease - a Pilot Study (English)
- ClinicalTrials.gov ID
- NCT01365767
- Acronym / sponsor ID
- KULT / HGRWLBKULT1
- Conditions
- Crohn Disease
- Keywords
- Crohn disease, Ultrasonography, contrast enhanced, Elasticity Imaging Techniques, Small intestine, Magnetic Resonance Imaging, CDAI, Calprotectin, IBD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Rune WilkensUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 3 Jun 2011 (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 study is to determine how relevant dynamic ultrasound scans using contrast agents (SonoVue) is in the diagnosis of Crohns disease in the small bowel, compared to dynamic Magnetic Resonance Imaging (MRI) of the small bowel.
Detailed description
Crohns disease (CD) is a lifelong chronic Inflammatory Bowel Disease (IBD) normally with an early debut. It requires continuous evaluation with either endoscopy, Magnetic Resonance Imaging (MRI), Computed Tomography (CT) or Wireless Capsule Endoscopy (WCE). These methods are either expensive, invasive or with uses radiation. Therefore UltraSound (US), as a cheap, fast and well tolerated examination of the small bowel are tested against the the validated MRI examination of the small bowel. Both examinations are using intra venous (i.v.) contrast agents. Obtained results are compared to disease activity.
Hypothesis is, that dynamic US is comparable to dynamic MRI and therefore should be the first examination of choice in evaluating patients with CD.
This study is a pilot study only.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Crohn Disease | – | –Patients with Crohns Disease referred to referred to a Magnetic Resonance Imaging Scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated on Regional Hospital of Silkeborg.
Key inclusion criteria (3 listed)
- Patients with known Crohns Disease
- 18 years old or older.
- Referred to a Magnetic Resonance Imaging scan of the small bowel
Key exclusion criteria (14 listed)
- Contraindications to or not suitable of a Magnetic Resonance Imaging
- Liver transplant
- nursing og pregnancy
- Known Allergy of SonoVue
- Acute Myocardial infarction < 4 weeks
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
Correlation between time-intensity curves of dynamic ultrasound and dynamic Magnetic Resonance Imaging
Time frame: up to 1 week
Time intesity curves are obtained using intra venous contrast agents during Magnetic Resonance Imaging scans and Ultrasound examination of the small bowel
5 secondary outcomes
Correlation between elastography scans of Magnetic Resonance Imaging and Ultrasound of the small bowel
Time frame: up to 1 week
Correlation between Doppler Score and Contrast Enhanced Ultrasound Score
Time frame: up to 1 week
Correlation between greatest bowel wall thickness and disease activity measured in Ultrasound and Magnetic Resonance Imaging
Time frame: up to 1 week
Correlation between Ultrasound score and Faeces Calprotectin
Time frame: up to 2 months
Correlation between Crohns disease activity index and Ultrasound score
Time frame: up to 2 months
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 16 Jul 2013.
Related trials for Crohn Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
Henning Glerup study chair
Region Hospital of Silkeborg
Rune Wilkens principal investigator
Region Hospital of Silkeborg
Lars B. Hansen principal investigator
Aarhus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Rune Wilkens at 2 sites 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 3 inclusion and 14 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 16 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Correlation between time-intensity curves of dynamic ultrasound and dynamic Magnetic Resonance Imaging (time frame: up to 1 week). 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 16 Jul 2013.