NCT01044173

Brief Summary

At present, CT is the gold standard in the assessment of patients with acute abdomen. Yet, one CT of the abdomen exposes patients to a radiation dose equivalent to several years of background radiation. MR can be expected to yield the same information without ionizing radiation, but tends to be more time consuming. In this study, patients with nontraumatic acute abdominal pain referred to CT of the abdomen by the department of surgery will also have performed an additional MR scan covering the entire abdomen with few fast imaging sequences in approximately 15min. CT is the diagnostic test. The MR scan is only used for scientific purposes. It will be evaluated by a radiologist blinded for the results of the CT scan. Fourteen days after admission, a final diagnosis is established based on clinical, peroperative, pathological and lab. findings. The performance of CT and MR will then be compared. The investigators hypothesize that MR can provide a diagnostic accuracy comparable to CT.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
withdrawn

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

January 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2010

Completed
1.7 years until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

11 months

First QC Date

January 6, 2010

Last Update Submit

January 29, 2017

Conditions

Keywords

acute abdomenCTMRIfast imaging

Outcome Measures

Primary Outcomes (1)

  • diagnostic accuracy of CT vs. MR

    14 days

Interventions

MR scanDEVICE

axial and coronal free breathing HASTE sequences 3D T1 weighted gradient echo breathhold

Eligibility Criteria

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

You may qualify if:

  • Signed informed consent form
  • Age \> 18 years old
  • Nontraumatic acute abdomen
  • Weight \< 120kg
  • Can keep apnoea for 15s
  • Surgeon in charge considers patient fit for participation in study

You may not qualify if:

  • Contraindications of MRI
  • Suspicion of acute vascular disease
  • Severe cardial or pulmonal insufficiency
  • Pregnancy
  • Untreated psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Koege Sygehus

Koege, DK4600, Denmark

Location

Related Publications (1)

  • Stoker J. Magnetic resonance imaging and the acute abdomen. Br J Surg. 2008 Oct;95(10):1193-4. doi: 10.1002/bjs.6378. No abstract available.

    PMID: 18763236BACKGROUND

MeSH Terms

Conditions

Abdomen, Acute

Condition Hierarchy (Ancestors)

Abdominal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Thomas Jørgensen, MD

    Zealand University Hospital

    PRINCIPAL INVESTIGATOR
  • Jens Maier, MD

    Zealand University Hospital

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
overlæge, radiologisk afdeling, Køge sygehus

Study Record Dates

First Submitted

January 6, 2010

First Posted

January 7, 2010

Study Start

October 1, 2011

Primary Completion

September 1, 2012

Study Completion

October 1, 2012

Last Updated

January 31, 2017

Record last verified: 2017-01

Locations