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Validation of an IUS Activity Index

NCT05407350 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2022-06-07

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • International Bowel Ultrasound Group e.V.

    lead OTHER

Principal Investigators

  • Kerri Novak, Prof · University of Calgary

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2024-06-30
Completion
2025-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05407350 on ClinicalTrials.gov