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Dark Lumen MR colonography vs. Colonoscopy for the detection of colorectal lesions

Conditions
colorectal carcinoma
large bowel cancer
10017990
10017991
Registration Number
NL-OMON32956
Lead Sponsor
Academisch Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
110
Inclusion Criteria

-Symptomatic CRC patients ( rectal blood loss, altered bowel habits)
-Patients scheduled to undergo colonoscopy
-Patients who are willing to give informed consent

Exclusion Criteria

-Age of less than 18 years
-patients who were unable to give informed consent
-any suspicion of bowel perforation or pathologic obstruction in subjects* medical history
-contraindications for oral or intravenous administration of contrast agents as used for this examination
-oral or intravenous administration of barium contrast medium within 48 hours prior to MR colonography (barium enema)
-presence of a colostomy after colorectal surgery
-contraindications to undergo MRI (including claustrophobia, metallic implants and pregnancy)

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The main study endpoint is the diagnostic accuracy of MR colonography in<br /><br>detecting patients with colorectal carcinoma (CRC) , clinical relevant polyps<br /><br>(* 10mm) and intermediate polyps (6-9mm). </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary endpoints are evaluation of the per-polyp detection and patient<br /><br>acceptance.</p><br>
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