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MR Colonography With Fecal Tagging. Barium vs. BariumFerumoxsil

MR Colonography With Fecal Tagging. Barium vs. BariumFerumoxsil

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00332943
Enrollment
20
Registered
2006-06-02
Start date
2005-12-31
Completion date
2006-05-31
Last updated
2007-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Polyps

Keywords

colorectal polyps, colorectal cancer, Virtual colonoscopy, Fecal tagging, MR colonography

Brief summary

The purpose of this study is to determine whether Barium or BariumFerumoxsil is better for fecal tagging in MR colonography. Patients referred to colonoscopy are offered MR colonography before colonoscopy. Two days before colonography, patients ingest either a contrast agent A (200 ml Barium sulphate solution 1g/ml)) four times a day or a 200 ml contrast agent B (Barium sulfate(25%) and Ferumoxil(75%)) four times a day, which will render fecal masses invisible on the following MR colonography. The patients are randomised to either contrast agent A or B. The examinations are evaluated by two independent blinded readers, who will rate the tagging quality of the contrast agents. The quality of tagging will be rated by a Visual Analog Scale (VAS) and Relative contrast (ReCon = Iwall - Ilumen/ Iwall + Ilumen).

Interventions

PROCEDUREMR colonography with fecal tagging

Sponsors

University Hospital, Gentofte, Copenhagen
CollaboratorOTHER
Herlev Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Suspicion of colorectal polyps or cancer * Referred for colonoscopy

Exclusion criteria

* Suspicion of IBD * Pacemaker * Metal in the body * Claustrophobia * Pregnancy

Design outcomes

Primary

MeasureTime frame
Sensitivity of VAS score vs. ReCon score
Quality of fecal tagging agent

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026