NCT00332943

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_4 colorectal-cancer

Timeline
Completed

Started Dec 2005

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

Study Start

First participant enrolled

December 1, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2006

Completed
Last Updated

September 20, 2007

Status Verified

September 1, 2007

First QC Date

June 1, 2006

Last Update Submit

September 19, 2007

Conditions

Colorectal CancerPolyps

Keywords

colorectal polypscolorectal cancerVirtual colonoscopyFecal taggingMR colonography

Outcome Measures

Primary Outcomes (2)

  • Quality of fecal tagging agent

  • Sensitivity of VAS score vs. ReCon score

Interventions

MR colonography with fecal taggingPROCEDURE

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

Copenhagen, 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, MD

    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 1, 2006

First Posted

June 2, 2006

Study Start

December 1, 2005

Study Completion

May 1, 2006

Last Updated

September 20, 2007

Record last verified: 2007-09

Locations

DK(1)