A Pilot Study on the use of contrast enhanced ultrasound in Crohn’s disease

• Conditions: Inflammatory bowel disease (Crohn's disease); MedDRA version: 18.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-002882-41-AT
• Lead Sponsor: Medical University of Vienna (MUW)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-05
• Last Update Posted: 1 February 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1) Men and women above the age of 18 with an established diagnosis of Crohn’s disease for at least 3
months (according to a histology from an ileocolonoscopy evidentiary
for Crohn’s disease)
2) Able and willing to provide written informed consent
3) Crohn’s disease with evidence
of ileal or ileocolonic disease
4) Clinically active disease as evidenced by a Harvey Bradshaw index of 8 or above
5) Planned step-­-up in immunosuppressive therapy with an antiTNFalpha agent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

1) Ulcerative colitis or indeterminate colitis
2) Isolated colonic Crohn’s disease
3) Contraindications for undergoing magnetic resonance imaging with computed tomography or other methods planned to be applied for disease/response assessment as substitute for MRI
4) Contraindications to undergo contrast enhanced ultrasound examinations
5) Contraindications against therapy with an antiTNFalpha agent
6) Inability to adhere to follow up schedule and/or provide information necessary to assess response parameters
7) Unwilling or unable to undergo blood sampling
8) Female subjects pregnant or planning pregnancy within the timeframe of the study participation
9) Significant coronary heart disease, right-to-­left, bidirectional, or transient right-­to-­left cardiac shunt

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified