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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01044173
First Posted: January 7, 2010
Last Update Posted: January 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jens Maier, Zealand University Hospital
  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: None (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:


Further study details as provided by Jens Maier, Zealand University Hospital:

Primary Outcome Measures:
  • diagnostic accuracy of CT vs. MR [ Time Frame: 14 days ]

Enrollment: 0
Study Start Date: October 2011
Study Completion Date: October 2012
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01044173


Locations
Denmark
Koege Sygehus
Koege, Denmark, DK4600
Sponsors and Collaborators
Zealand University Hospital
Investigators
Principal Investigator: Thomas Jørgensen, MD Zealand University Hospital
Study Director: Jens Maier, MD Zealand University Hospital
  More Information

Publications:
Responsible Party: Jens Maier, overlæge, radiologisk afdeling, Køge sygehus, Zealand University Hospital
ClinicalTrials.gov Identifier: NCT01044173     History of Changes
Other Study ID Numbers: N-20090033
First Submitted: January 6, 2010
First Posted: January 7, 2010
Last Update Posted: January 31, 2017
Last Verified: January 2017

Keywords provided by Jens Maier, Zealand University Hospital:
acute abdomen
CT
MRI
fast imaging

Additional relevant MeSH terms:
Abdomen, Acute
Abdominal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive