NCT00114842

CompletedPhase 4

Magnetic Resonance (MR) Colonography With Fecal Tagging

Herlev Hospital Source

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Other study identifiers

Sponsor study identifier

KA05029-MA

Secondary identifiers

KA05029

Study Type

interventional

Estimated enrollment

60

Locations

1 country

Sites

1

Timeline

Study Start

March 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

March 2007

Actual (reported)

Brief Summary

The purpose of this study is to determine if MR colonography with fecal tagging is better using air or water for distension of the colon. Patients referred to colonoscopy are offered MR colonography before colonoscopy. Two days before colonography, patients ingest a 200 ml Barium sulfate solution 2% four times a day, which will render fecal masses "invisible" on the following MR colonography. Air or water (randomised trial) is used for distension of the colon. The examinations are evaluated by two independent blinded readers.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 60 participants
Study completion date: March 2007
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
June 17, 2005
Actual (reported)
First Posted
June 20, 2005
Actual (reported)
Study Start
March 2006
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
March 2007
Actual (reported)

Last Updated: September 20, 2007
Status Verified: September 2007
Last Update Submitted: September 19, 2007

Conditions

Colorectal Cancer Polyps

Keywords

colorectal polypscolorectal cancerVirtual colonoscopyFecal taggingMR colonography

Outcome Measures

Primary Outcomes (1)

Sensitivity/specificity for water versus air for distension of colon in MR colonography

Secondary Outcomes (2)

Feasibility of MR colonography with fecal tagging
Sensitivity/specificity of MR colonography versus colonoscopy

Interventions

MR colonographyProcedure

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Suspicion of colorectal polyps or cancer
Referred for colonoscopy

You may not qualify if:

Sponsors & Collaborators

University Hospital, Gentofte, Copenhagen
Othercollaborator
Herlev Hospital
Otherlead

Study Sites (1)

Department of Radiology Copenhagen University Hospital Herlev

Herlev, DK-2730, Denmark

MeSH Terms

Conditions

Colorectal NeoplasmsPolyps

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

Michael P Achiam, M.D.
Department of Radiology Copenhagen University Hospital Herlev
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: SINGLE
Purpose: DIAGNOSTIC
Intervention Model: PARALLEL
Sponsor Type: OTHER

Study Record Dates

First Submitted

June 17, 2005

First Posted

June 20, 2005

Study Start

March 2006

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

March 2007

Actual (reported)

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Suspicion of IBD
Pacemaker
Metal in the body
Claustrophobia
Pregnancy

Contact the study team to confirm eligibility.

Last Updated

September 20, 2007

Record last verified: 2007-09

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT00114842
Data provider: ClinicalTrials.gov
Source updated: 2007-09-20
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:18:27 UTC

Locations

DK(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations