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Plain Magnetic Resonance (MR) in the Assessment of Patients With Acute Abdomen

This study is currently recruiting participants.
Verified October 2011 by Koege Sygehus
Sponsor:
Information provided by (Responsible Party):
Jens Maier, Koege Sygehus
ClinicalTrials.gov Identifier:
NCT01044173
First received: January 6, 2010
Last updated: October 24, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention
Acute Abdomen
 Device: MR scan

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Assessment of Patients With Nontraumatic Acute Abdominal Pain With Plain MR of the Abdomen - a Comparison With CT

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Koege Sygehus:

Primary Outcome Measures:
  • diagnostic accuracy of CT vs. MR [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: October 2011
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: MR scan
    axial and coronal free breathing HASTE sequences 3D T1 weighted gradient echo breathhold
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Contraindications of MRI
  • Suspicion of acute vascular disease
  • Severe cardial or pulmonal insufficiency
  • Pregnancy
  • Untreated psychiatric illness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044173

Contacts
Contact: Jens Maier, MD ++45 47325418 jefm@regionsjaelland.dk

Locations
Denmark
Koege Sygehus Recruiting
Koege, Denmark, DK4600
Contact: Jens Maier, MD     ++45 47325418     jefm@regionsjaelland.dk    
Principal Investigator: Jens Maier, MD            
Sponsors and Collaborators
Koege Sygehus
Investigators
Principal Investigator: Thomas Jørgensen, MD Koege Sygehus
Study Director: Jens Maier, MD Koege Sygehus
  More Information

Publications:

Responsible Party: Jens Maier, overlæge, radiologisk afdeling, Køge sygehus, Koege Sygehus
ClinicalTrials.gov Identifier: NCT01044173     History of Changes
Other Study ID Numbers: N-20090033
Study First Received: January 6, 2010
Last Updated: October 24, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: National Board of Health

Keywords provided by Koege Sygehus:
acute abdomen
CT
MRI
fast imaging

Additional relevant MeSH terms:
Abdomen, Acute
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on May 16, 2013