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

Primary Purpose

Acute Abdomen

Status
Withdrawn
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
MR scan
Sponsored by
Zealand University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Abdomen focused on measuring acute abdomen, CT, MRI, fast imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Koege Sygehus

Outcomes

Primary Outcome Measures

diagnostic accuracy of CT vs. MR

Secondary Outcome Measures

Full Information

First Posted
January 6, 2010
Last Updated
January 29, 2017
Sponsor
Zealand University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01044173
Brief Title
Plain Magnetic Resonance (MR) in the Assessment of Patients With Acute Abdomen
Official Title
Assessment of Patients With Nontraumatic Acute Abdominal Pain With Plain MR of the Abdomen - a Comparison With CT
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Withdrawn
Study Start Date
October 2011 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zealand University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Abdomen
Keywords
acute abdomen, CT, MRI, fast imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
MR scan
Intervention Description
axial and coronal free breathing HASTE sequences 3D T1 weighted gradient echo breathhold
Primary Outcome Measure Information:
Title
diagnostic accuracy of CT vs. MR
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Jørgensen, MD
Organizational Affiliation
Zealand University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jens Maier, MD
Organizational Affiliation
Zealand University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Koege Sygehus
City
Koege
ZIP/Postal Code
DK4600
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
18763236
Citation
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.
Results Reference
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Plain Magnetic Resonance (MR) in the Assessment of Patients With Acute Abdomen

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