NCT02364973

Brief Summary

The main purpose of the present study is to examine the diagnostic performance of combined PET-MRI in detecting colonic and small bowel wall inflammatory processes caused by ulcerative colitis and Crohn's disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2014

Longer than P75 for all trials

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

November 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 3, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

5.1 years

First QC Date

December 3, 2014

Last Update Submit

March 31, 2021

Conditions

IBD

Outcome Measures

Primary Outcomes (1)

  • The percentage of patients with active inflammation detected by PET-MRI

    COMBINED PET-MRI IN THE DIAGNOSTICS AND FOLLOW-UP OF CHRONIC INFLAMMATORY BOWEL DISEASES

    3 YEARS

Study Arms (1)

PET-MRI

Patients with chronic inflammatory bowel disease who are treated at Turku University hospital outpatient clinic or ward

Other: PET-MRI

Interventions

PET-MRIOTHER

The study patients undergo positron emission tomography (PET) after informed consent is obtained

PET-MRI

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

IBD patients living in the Turku University Hospital referral area

You may qualify if:

  • age over 18 years
  • IBD (ulcerative colitis or Crohn's disease diagnosed by endoscopy and/or radiology
  • no previous abdominal surgery
  • no biological therapy for IBD

You may not qualify if:

  • pregnancy
  • diabetes
  • the patient is unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, 20521, Finland

Location

Study Officials

  • Markku Voutilainen, MD

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2014

First Posted

February 18, 2015

Study Start

November 1, 2014

Primary Completion

December 1, 2019

Study Completion

August 1, 2020

Last Updated

April 1, 2021

Record last verified: 2021-03

Locations

FI(1)