NCT03435016

Brief Summary

The aim of this study is to evaluate non-invasive imaging techniques for assessing treatment response in known Crohn's disease.

  1. 1.Comparing imaging modalities:
  2. 2.Sensitivity and specificity for ulcer healing
  3. 3.Changes in activity parameters for SBCCE, MREC and US before and after medical treatment.
  4. 4.Feasibility of SBCCE, MREC and US for assessing treatment response in known Crohn's disease.
  5. 5.Treatment induced bowel wall alterations visualized with ultrasound:
  6. 6.A non-blinded study of bowel wall changes detected with repeated US examination during medical treatment of known Crohn's disease.
  7. 7.Changes in bowel wall thickness, vascularity and elastography parameters, and time to normalization of the bowel wall.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 2, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 15, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

5.1 years

First QC Date

February 2, 2018

Last Update Submit

November 27, 2023

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy

    Sensitivity and specificity of SBCCE, MREC and US for the diagnosis of ulcer healing in the terminal ileum and colon

    8-10 weeks

Secondary Outcomes (5)

  • Diagnostic accuracy fCal

    8-10 weeks

  • Diagnostic accuracy CRP

    8-10 weeks

  • Bowel wall thickening

    8-10 weeks

  • Elastography

    8-10 weeks

  • Ultrasound activity index

    8-10 weeks

Study Arms (1)

Diagnosis

OTHER
Diagnostic Test: Diagnostic work-up

Interventions

Diagnostic work-upDIAGNOSTIC_TEST

Patients are examined with all modalities. MR enterocolonography, ultrasound, and small bowel capsule endoscopy are compared against ileocolonoscopy (gold standard).

Also known as: Ileocolonoscopy, MR enterocolonography, Ultrasound, Small bowel colon capsule endoscopy
Diagnosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • An established diagnosis of CD
  • Age \> 18 years
  • Ileocolonoscopy: Endoscopically active CD (SES-CD ≥ 3)
  • Clinically active CD (Harvey-Bradshaw Index ≥ 5 or Crohn's Disease Activity Index ≥ 150)
  • Clinical indication for medical treatment with corticosteroids or biological therapy
  • Signed informed consent

You may not qualify if:

  • Acute bowel obstruction
  • Pregnancy or lactation
  • Alcohol or drug abuse
  • Known gastrointestinal disorder other than inflammatory bowel disease
  • Renal failure defined by a plasma-creatinine above the normal reference range
  • Claustrophobia, cardiac pacemaker or implanted magnetic foreign bodies that precludes MREC
  • Interpreter required or inability to understand the oral and written information
  • Bowel surgery performed between pre- and post-treatment assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sygehus Lillebaelt

Vejle, 7100, Denmark

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

UltrasonographyEndoscopy

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Michael D Jensen, MD, PhD

    Lillebaelt Hospital Vejle

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 2, 2018

First Posted

February 15, 2018

Study Start

February 1, 2018

Primary Completion

March 1, 2023

Study Completion

June 1, 2023

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

Individual participant data will not be available to other researchers.

Locations

DK(1)