NCT00300547

Brief Summary

The purpose of this study is to diagnose possible synchronous carcinomas and polyps with magnetic resonance (MR) colonography in patients booked for operation because of carcinoma in the descending or sigmoid colon, where a preoperative full colonoscopy is not possible. Two days before colonography, patients ingest a 200 ml Barium sulfate solution four times a day, which will render fecal masses "invisible" on the following MR colonography. The study is primarily a feasibility study with altered operative strategy as a secondary end-point. Gold standard is colonoscopy and operation.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 9, 2006

Completed
12 months until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Last Updated

August 18, 2010

Status Verified

March 1, 2006

Enrollment Period

1.1 years

First QC Date

March 8, 2006

Last Update Submit

August 17, 2010

Conditions

Obstructing Colorectal Cancer

Keywords

colorectal cancerpolypsVirtual colonoscopysynchronous carcinomaMR colonography

Outcome Measures

Primary Outcomes (1)

  • Feasibility of MR colonography to diagnose possible synchronous carcinomas and polyps

    3

Secondary Outcomes (1)

  • Altered operative strategy due to findings on MR colonography

    3

Interventions

MR colonographyPROCEDURE

Altered planned surgical procedure if MR colonoscopy reveals synchronous cancer or larger polyps

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Obstructing colorectal cancer

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, 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, MD

    Department of Radiology Copenhagen University Hospital Herlev

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 8, 2006

First Posted

March 9, 2006

Study Start

March 1, 2007

Primary Completion

April 1, 2008

Last Updated

August 18, 2010

Record last verified: 2006-03

Locations

DK(1)