NCT04324632

Brief Summary

Assess the accuracy of magnetic resonance-enterography in predicting the extension, location and characteristics of the small bowel segments affected by Crohn's disease\& determine the diagnostic performance of standard MR enterography in detecting colonic inflammation and investigate MR enterography's ability to grade inflammatory activity and detect intestinal extra intestinal manifestations

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2020

Status
unknown

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

First Submitted

Initial submission to the registry

March 25, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

1.9 years

First QC Date

March 25, 2020

Last Update Submit

March 25, 2020

Conditions

Keywords

MRE

Outcome Measures

Primary Outcomes (1)

  • comparison of magnetic resonance enterography findings with colonoscopic findings and clinical activity scores of IBD

    To investigate MR enterography's ability to detect to the extension, location and characteristics of intestinal segments affected by IBD and grade inflammatory activity in correlation with endoscopic findings.

    two years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

subjects of both sexes with different age groups diagnosed to have inflammatory bowel disease

You may qualify if:

  • Patients with different age groups and both sex are eligible for our prospective study
  • Either they had undergone colonoscopy or colonoscopy was planned, and they have been recently diagnosed with IBD.
  • Suspected to have disease relapse.

You may not qualify if:

  • Participants are not eligible for our prospective study if they:
  • Have evidence of severe or uncontrolled systemic disease that rendered the individual unsuitable for participation.
  • Have contraindications to MRE (e.g. allergy to all suitable contrast agents, cardiac pacemaker, severe claustrophobia, an inability to lie flat).
  • Had a final diagnosis other than IBD.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Central Study Contacts

Hayam Yahia Hamed Khalil, assisstant lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal invistigator

Study Record Dates

First Submitted

March 25, 2020

First Posted

March 27, 2020

Study Start

April 1, 2020

Primary Completion

March 1, 2022

Study Completion

April 1, 2022

Last Updated

March 27, 2020

Record last verified: 2020-03