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Validation of an IUS Activity Index (USE-IT)

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ClinicalTrials.gov Identifier: NCT05407350
Recruitment Status : Not yet recruiting
First Posted : June 7, 2022
Last Update Posted : June 7, 2022
Sponsor:
Information provided by (Responsible Party):
International Bowel Ultrasound Group e.V.

Brief Summary:
The primary objective of this study is to prospectively validate a novel intestinal ultrasound (IUS) Crohn's disease (CD) activity index and component items, correlating CD activity and responsiveness to therapy as evaluated by IUS with evaluations by ileocolonoscopy (IC) (Simple Endoscopic Score for Crohn's disease [SES-CD]) and magnetic resonance enterography (MRE) (Simplified Magnetic Resonance Index of Activity [MaRIA] score).

Condition or disease Intervention/treatment
Crohn Disease Diagnostic Test: Ultrasound, Colonoscopy, MRE

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of an Intestinal Ultrasound Score Evaluating Inflammation and Treatment Response in Crohn's Disease (USE-IT): A Prospective Multicenter Study
Estimated Study Start Date : June 2022
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Crohns disease patients
Adult patients with moderately to severely active CD
Diagnostic Test: Ultrasound, Colonoscopy, MRE
After the initiation of an established treatment of known efficacy for CD (biologic agents including infliximab, adalimumab, ustekinumab or vedolizumab either with or without corticosteroids), repeat IC and MRE will occur at Week 30 (± 6 weeks) (6-9 months); the IUS, IC, and MRE examinations will occur within a 4-week window and with no intervening change in medical therapy. All imaging data will be captured electronically (IUS and MRE with Digital Imaging and Communications in Medicine [DICOM] images, and IC with video recordings) for central, blinded reading. Two biopsies will be collected from each segment of the bowel (rectum, sigmoid, descending, transverse, ascending and terminal ileum) during IC, fixed in formalin collection containers, and shipped for histopathology processing and evaluation.
Other Names:
  • Collection of blood
  • Collection of Stuhl
  • Biopsie




Primary Outcome Measures :
  1. The longitudinal and construct validity and treatment responsiveness of an IUS CD activity index in an adult population with moderate to severely active CD [ Time Frame: week 0 to week 50 ]
    The newly formed activity index determined by intestinal ultrasound is compared with the results of colonoscopy (IC), MRE, blood and stool markers.


Secondary Outcome Measures :
  1. The correlation of IUS CD activity index and component items with IC [ Time Frame: week 0 to week 50 ]
    Disease activity determined by intestinal ultrasound is compared with the results of colonoscopy (IC) examinations.

  2. The correlation of IUS CD activity index and component items with MRE [ Time Frame: week 0 to week 50 ]
    Disease activity determined by intestinal ultrasound is compared with the results of MRE examinations.

  3. The correlation of IUS CD activity index and component items with biomarkers [ Time Frame: week 0 to week 50 ]
    Disease activity determined by intestinal ultrasound is compared with the results of Biomarker analysis.

  4. The correlation of IUS CD activity index and component items with histology [ Time Frame: week 0 to week 50 ]
  5. The correlation of IUS CD activity index and component items with HRQoL (SIBDQ) and PRO-2 [ Time Frame: week 0 to week 50 ]
    Disease activity determined by intestinal ultrasound is compared with the results of patient-reported outcomes HRQoL (SIBDQ) and PRO-2.


Biospecimen Retention:   Samples Without DNA
Blood, Stuhl, Biopsies


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population

This study is a multicenter, international, nonrandomized prospective cohort study across multiple sites in North America, Australia, and Europe.

The study population will consist of 111 adult participants with moderately to severely active CD managed as per SOC, in established IBD expert centers with access to IUS, IC, and MRE procedures.

Criteria

Inclusion Criteria:

  1. Confirmed diagnosis of CD according to standard clinical, endoscopic, and histologic criteria of at least 3 months duration
  2. Adults 18 years of age or older
  3. Moderate to severely active CD defined by:

    1. Active symptoms with a HBI ≥ 8, and
    2. Bowel wall inflammation defined as BWT > 3 mm in at least 1 segment of the ileum or colon as determined by IUS
  4. Patients with planned introduction of biologic therapy as per their treating gastroenterologist to treat active disease
  5. Written informed consent must be obtained and documented.

Exclusion Criteria:

  1. Patients with a primary diagnosis of ulcerative colitis or IBD type unclassified
  2. Patients with prior intestinal surgery
  3. Patients with disease-related structural bowel complications defined as either:

    1. Stricture with increased bowel wall thickening (>25% of normal), decreased luminal diameter (>50% relative to the normal adjacent bowel loop) and proximal dilation (on any imaging modality) or;
    2. Penetrating complications (excluding perianal fistulizing disease; patients with perianal disease are eligible if there is additional inflammation in another bowel segment [other than the rectum]).
  4. Contraindication to IC or MRE
  5. BMI greater than 35 at time of screening or other characteristics considered likely to preclude IUS visualization of all bowel segments
  6. Disease limited to the rectum
  7. Serious underlying disease other than CD that in the opinion of the investigator may interfere with the participant's ability to participate fully in the study
  8. History of alcohol or drug abuse that in the opinion of the investigator may interfere with the participant's ability to comply with the study procedures
  9. Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05407350


Contacts
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Contact: Jimmi Cording, PhD 004915129110689 jc@bowel-ultrasound.org
Contact: Carmen Treubrodt 00491744344130 ct@bowel-ultrasound.org

Locations
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Germany
IBUS office
Berlin, Germany, 12161
Contact: Jimmi Cording, PhD    004915129110689    jc@bowel-ultrasound.org   
Contact: Carmen Treubrodt    00491744344130    ct@bowel-ultrasound.org   
Sponsors and Collaborators
International Bowel Ultrasound Group e.V.
Investigators
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Principal Investigator: Kerri Novak, Prof University of Calgary
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Responsible Party: International Bowel Ultrasound Group e.V.
ClinicalTrials.gov Identifier: NCT05407350    
Other Study ID Numbers: USE-IT-01434
First Posted: June 7, 2022    Key Record Dates
Last Update Posted: June 7, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by International Bowel Ultrasound Group e.V.:
intestinal ultrasound
MRE
Colonoscopy
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases