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

• Register: EUCTR
• Last refreshed on: 1 February 2016
• Main ID: EUCTR2015-002882-41-AT
• Date of registration: 05/11/2015
• Prospective Registration: Yes
• Primary sponsor: Medical University of Vienna (MUW)
• Public title: A Pilot Study on the use of contrast enhanced ultrasound in Crohn’s disease
• Scientific title: Sono-­Response-­Study A Pilot Study on the use of contrast enhanced ultrasound in Crohn’s disease
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002882-41
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Austria

Contacts

• Name: Working Party IBD
• Affiliation: Universitätsklinik fu¨r Innere Medizin III, Klinische Abteilung fu¨r Gastroenterologie und Hepatologie

• Name: Working Party IBD
• Affiliation: Universitätsklinik fu¨r Innere Medizin III, Klinische Abteilung fu¨r Gastroenterologie und Hepatologie

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Inflammatory bowel disease (Crohn's disease)
MedDRA version: 18.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Trade Name: SonoVue
Product Name: SonoVue
Pharmaceutical Form: Gas and solvent for dispersion for injection/infusion
INN or Proposed INN: sulphur hexafluoride
CAS Number: 2551-62-4
Other descriptive name: SULFUR HEXAFLUORIDE
Concentration unit: µl/ml microlitre(s)/millilitre
Concentration type: equal
Concentration number: 8-

Primary Outcome(s)

Primary end point(s): To assess the predicitve capacity of contrast enhanced ultrasound for response assessment in Crohn’s disease patients under newly established therapy with antiTNFalpha treatment, measured at week 12 (stratified by the Harvey Bradshaw Index in responders and non responders).

Timepoint(s) of evaluation of this end point: Week 12

Main Objective: To assess the predicitve capacity of contrast enhanced ultrasound for response assessment in Crohn’s disease patients under newly established therapy with antiTNFalpha treatment (stratified by the Harvey Bradshaw Index in responders and non responders).

Secondary Objective: Assess the predictive capacity of CEUS for response assessment in Crohn’s disease patients under newly established therapy with antiTNFalpha treatment with biometrical parameters as stratifiers for response (fCP).
Correlate results from CEUS with
-­ MRI
-­ Change of fecal calprotectin (Visit 1 versus Visit 2, 3 and 4)
Correlate results form MRI with
-­ Change in disease activity scores
-­ Change of fecal calprotectin (Visit 1 versus Visit 2, 3 and 4)

Secondary Outcome(s)

Secondary end point(s): Correlate results from CEUS with
- MRI
- Change of fecal calprotectin
Correlate results form MRI with
- Change in disease activity scores
- Change of fecal calprotectin

Timepoint(s) of evaluation of this end point: Visit 1 versus Visit 2 (week 4), 3 (week 12) and 4 (week 24)

Secondary ID(s)

AIBDSG_002

Source(s) of Monetary Support

Universitätsklinik fu¨r Innere Medizin III, Klinische Abteilung fu¨r Gastroenterologie und Hepatologie