Calculating the LEmann IndeX Using InTEstiNal Ultrasound

NCT06647823 | Not Yet Recruiting

• 1 other identifier: #2302-06591
• Study Type: observational
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to assess and quantitatively measure structural bowel damage in Crohn's disease (CD) with the Lèmann-Index (LI) for Intestinal Ultrasound (IUS). IUS is a non-invasive, easily repeated and well tolerated tool with no bowel preparations. With this study the investigators aim to show that IUS can replace Magnetic Resonance Enterography (MRE), which has been used to develop the original Lèmann-Index, to evaluate structural bowel damage. For each patient, IUS and MRE (and Colonoscopy, if the colon is involved) will be performed within a two-month timeframe.

Conditions

Crohn Disease (CD)

Keywords

EXTENT; Intestinal Ultrasound; Lèmann Index; Bowel damage; Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Intraclass correlation between the LI-IUS scores and the LI-MRE scores assessing small bowel damage and colon damage in patients with CD.

  Baseline

Secondary Outcomes (11)

• Intraclass correlation between the LI-IUS and LI-MRE segmental damage scores (terminal ileum) and LI-IUS and LI-MRE+colonoscopy (all colonic segments, except rectum).

  Baseline

• Intraclass correlation between the LI-IUS scores and the LI-MRE + colonoscopy scores in assessing colon damage in patients with CD.

  Baseline

• Intraclass correlation between the LI-IUS scores and the LI-MRE scores assessing small bowel damage and colon damage in patients with CD.

  Baseline

• Intraclass correlation between the small bowel, colon and global LI-IUS and LI-MRE scores by local investigators and central readers.

  Baseline

• Acceptability rate of IUS, MRE and colonoscopy.

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

EXTENT will be a multicenter, cross-sectional study including 102 Crohn's disease patients, stratified by known or suspected CD location (small bowel and colon) and by disease duration (\< 2 years, ≥ 2 years and \< 10 years, and ≥ 10 years). The investigators will recruit patients with an established diagnosis of CD, with no restriction per disease activity, surgical history or CD medication.

You may qualify if:

• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any Screening procedures.
• Patients with a previously documented CD diagnosis confirmed by clinical, endoscopic, histological, and/or radiological criteria.
• Age ≥18 years old.
• Examinations needed as standard of care.

You may not qualify if:

• Pregnancy and female patients of child-bearing potential planning a pregnancy during the study period
• Patients with a primary diagnosis of ulcerative colitis or IBD unclassified or microscopic colitis
• Patients with disease limited to the upper GI tract, rectum or perianal CD
• Patients with a contraindication for MR, colonoscopy and/or ultrasound
• Patients with allergy to gadolinium chelated or with eGFR\<60 mL/min/1.73m2
• Patients unwilling or unable to provide informed, written consent.

Sponsors & Collaborators

• International Bowel Ultrasound Group e.V.: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator

Related Publications (1)

• Palmela C, Torres J, Frias-Gomes C, Allocca M, Buisson A, Colombel JF, Novak K, Rimola J, Albshesh A, Bonifacio C, Krugliak Cleveland N, De Voogd F, Dolinger M, Furfaro F, Jauregui-Amezaga A, Karakan T, Kellar A, Kralj D, Lu C, Pruijt M, Rieder F, Madsen GR, Nagarajan KV, Sagami S, Scharitzer M, Stoker J, Taylor SA, Tews HC, Vanslembrouck R, Vaughan R, Wilkens R, Maaser C, Verstockt B. The EXTENT Study: Results From an International Expert Delphi Consensus to Define Ultrasonographic Parameters for Measuring Bowel Damage in Crohn's Disease. Clin Gastroenterol Hepatol. 2025 Jul 28:S1542-3565(25)00637-8. doi: 10.1016/j.cgh.2025.07.024. Online ahead of print.

  PMID: 40738277 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Routine blood samples (CRP, serum albumin, hemoglobin), stool samples (fcal)

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Daniela Wueller

CONTACT

+491742106195; dw@bowel-ultrasound.org

Study Design

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

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 18, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 23, 2024

Record last verified: 2024-10