Validation of an IUS Activity Index

NCT05407350 | Unknown

• 1 other identifier: USE-IT-01434
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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).

Conditions

Crohn Disease

Keywords

intestinal ultrasound; MRE; Colonoscopy

Outcome Measures

Primary Outcomes (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

  The newly formed activity index determined by intestinal ultrasound is compared with the results of colonoscopy (IC), MRE, blood and stool markers.

  week 0 to week 50

Secondary Outcomes (5)

• The correlation of IUS CD activity index and component items with IC

  week 0 to week 50

• The correlation of IUS CD activity index and component items with MRE

  week 0 to week 50

• The correlation of IUS CD activity index and component items with biomarkers

  week 0 to week 50

• The correlation of IUS CD activity index and component items with histology

  week 0 to week 50

• The correlation of IUS CD activity index and component items with HRQoL (SIBDQ) and PRO-2

  week 0 to week 50

Study Arms (1)

Crohns disease patients

Adult patients with moderately to severely active CD

Diagnostic Test: Ultrasound, Colonoscopy, MRE

Interventions

Ultrasound, Colonoscopy, MRE DIAGNOSTIC_TEST

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.

Also known as: Collection of blood, Collection of Stuhl, Biopsie

Crohns disease patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Confirmed diagnosis of CD according to standard clinical, endoscopic, and histologic criteria of at least 3 months duration
• Adults 18 years of age or older
• Moderate to severely active CD defined by:
• Active symptoms with a HBI ≥ 8, and
• Bowel wall inflammation defined as BWT \> 3 mm in at least 1 segment of the ileum or colon as determined by IUS
• Patients with planned introduction of biologic therapy as per their treating gastroenterologist to treat active disease
• Written informed consent must be obtained and documented.

You may not qualify if:

• Patients with a primary diagnosis of ulcerative colitis or IBD type unclassified
• Patients with prior intestinal surgery
• Patients with disease-related structural bowel complications defined as either:
• 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;
• Penetrating complications (excluding perianal fistulizing disease; patients with perianal disease are eligible if there is additional inflammation in another bowel segment \[other than the rectum\]).
• Contraindication to IC or MRE
• BMI greater than 35 at time of screening or other characteristics considered likely to preclude IUS visualization of all bowel segments
• Disease limited to the rectum
• 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
• 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
• Pregnancy

Sponsors & Collaborators

• International Bowel Ultrasound Group e.V.: lead

Study Sites (1)

IBUS office

Berlin, 12161, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, Stuhl, Biopsies

MeSH Terms

Conditions

Crohn Disease

Interventions

Ultrasonography; Colonoscopy; Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Kerri Novak, Prof

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jimmi Cording, PhD

CONTACT

004915129110689; jc@bowel-ultrasound.org

Carmen Treubrodt

CONTACT

00491744344130; ct@bowel-ultrasound.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: June 7, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: June 7, 2022

Record last verified: 2022-04

Locations

DE (1)