- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01044173
Plain Magnetic Resonance (MR) in the Assessment of Patients With Acute Abdomen
January 29, 2017 updated by: Jens Maier, Zealand University Hospital
Assessment of Patients With Nontraumatic Acute Abdominal Pain With Plain MR of the Abdomen - a Comparison With CT
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.
Study Overview
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Koege, Denmark, DK4600
- Koege Sygehus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
diagnostic accuracy of CT vs. MR
Time Frame: 14 days
|
14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas Jørgensen, MD, Zealand University Hospital
- Study Director: Jens Maier, MD, Zealand University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Anticipated)
September 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
January 6, 2010
First Submitted That Met QC Criteria
January 6, 2010
First Posted (Estimate)
January 7, 2010
Study Record Updates
Last Update Posted (Estimate)
January 31, 2017
Last Update Submitted That Met QC Criteria
January 29, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- N-20090033
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Abdomen
-
Assiut UniversityCompletedNon Enhanced MSCT Abdomen in Diagnosis of Acute AbdomenEgypt
-
Amal Fathy Abo ElgaradUnknown
-
Assiut UniversityUnknownUltra Sound in Diagnosis of Acute Abdomen in Pediatric Group
-
Assiut UniversityUnknownPatient Presented With Acute Abdomen | Patient Undergoing Urgent GIT Surgery
-
Pitié-Salpêtrière HospitalAssociation pour la Recherche et la Formation en Anesthésie Analgésie RéanimationCompleted
-
Michigan State UniversityCompleted
-
Kuopio University HospitalCompleted
-
Karolinska InstitutetRegion StockholmCompleted
-
Azienda Ospedaliero-Universitaria di ModenaCompleted
-
Zagazig UniversityCompleted
Clinical Trials on MR scan
-
Washington University School of MedicineCompleted
-
University of SouthamptonCompletedPatient Specific Computational ModelingUnited Kingdom
-
Tel-Aviv Sourasky Medical CenterUnknownSarcoma | Lymphoma | Cervical Cancer | Nasopharyngeal Cancer | Pancreatic Cancer | Esophageal Cancer | Prostate Cancer | Hepatobiliary Cancer
-
Tel-Aviv Sourasky Medical CenterUnknownNeuroendocrine Tumors
-
NYU Langone HealthIcahn School of Medicine at Mount SinaiRecruiting
-
University Health Network, TorontoPrincess Margaret Hospital, CanadaActive, not recruiting
-
AHS Cancer Control AlbertaRecruiting
-
Lahey ClinicVasSol®-Nova SoftwareWithdrawnIntracranial Arterial AneurysmUnited States
-
Case Comprehensive Cancer CenterActive, not recruitingBreast CancerUnited States