NCT01365767

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2011

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

July 16, 2013

Status Verified

July 1, 2013

Enrollment Period

4 months

First QC Date

May 27, 2011

Last Update Submit

July 15, 2013

Conditions

Crohn Disease

Keywords

Crohn diseaseUltrasonography, contrast enhancedElasticity Imaging TechniquesSmall intestineMagnetic Resonance ImagingCDAICalprotectinIBDSonography

Outcome Measures

Primary Outcomes (1)

  • 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

    up to 1 week

Secondary Outcomes (5)

  • Correlation between elastography scans of Magnetic Resonance Imaging and Ultrasound of the small bowel

    up to 1 week

  • Correlation between Doppler Score and Contrast Enhanced Ultrasound Score

    up to 1 week

  • Correlation between greatest bowel wall thickness and disease activity measured in Ultrasound and Magnetic Resonance Imaging

    up to 1 week

  • Correlation between Ultrasound score and Faeces Calprotectin

    up to 2 months

  • Correlation between Crohns disease activity index and Ultrasound score

    up to 2 months

Study Arms (1)

Crohn Disease

Patients with Crohns Disease referred to referred to a Magnetic Resonance Imaging Scan.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated on Regional Hospital of Silkeborg.

You may qualify if:

  • Patients with known Crohns Disease
  • years old or older.
  • Referred to a Magnetic Resonance Imaging scan of the small bowel

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aarhus University Hospital

Aarhus, DK-8000, Denmark

Location

Medical department, Regional Hospital of Silkeborg

Silkeborg, DK-8600, Denmark

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Henning Glerup

    Region Hospital of Silkeborg

    STUDY CHAIR

  • Rune Wilkens

    Region Hospital of Silkeborg

    PRINCIPAL INVESTIGATOR

  • Lars B. Hansen

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 27, 2011

First Posted

June 3, 2011

Study Start

May 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

July 16, 2013

Record last verified: 2013-07

Locations

DK(2)