NCT00114842

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 colorectal-cancer

Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_4 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 20, 2005

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

September 20, 2007

Status Verified

September 1, 2007

First QC Date

June 17, 2005

Last Update Submit

September 19, 2007

Conditions

Colorectal CancerPolyps

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

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:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiology Copenhagen University Hospital Herlev

Herlev, DK-2730, Denmark

Location

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 1, 2006

Study Completion

March 1, 2007

Last Updated

September 20, 2007

Record last verified: 2007-09

Locations

DK(1)