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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01044173
Other study ID # N-20090033
Secondary ID
Status Withdrawn
Phase N/A
First received January 6, 2010
Last updated January 29, 2017
Start date October 2011
Est. completion date October 2012

Study information

Verified date January 2017
Source Zealand University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
MR scan
axial and coronal free breathing HASTE sequences 3D T1 weighted gradient echo breathhold

Locations

Country Name City State
Denmark Koege Sygehus Koege

Sponsors (1)

Lead Sponsor Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary diagnostic accuracy of CT vs. MR 14 days
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