Magnetic Resonance (MR) Colonography With Fecal Tagging | NCT00114842

Studies
Magnetic Resonance (MR) Colonography With Fecal Tagging

NCT00114842

Sponsor

Herlev Hospital

Status

Completed

Last Update Posted

Sep 20, 2007Estimated

Enrollment

60Estimated

Phase

Phase 4

Conditions

Colorectal Cancer
Polyps

Interventions

MR colonography

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
KA05029

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Not provided

Completion Date

Mar 2007Actual

First Submitted Date

Jun 17, 2005

First Submission Date that Met QC Criteria

Jun 17, 2005

First Posted Date

Jun 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2007

Last Update Posted Date

Sep 20, 2007Estimated

Name	Class
University Hospital, Gentofte, Copenhagen	OTHER

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Name	Type	Description	Arm Group Labels	Other Names
MR colonography	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity/specificity for water versus air for distension of colon in MR colonography

Secondary Outcomes

Measure	Description	Time Frame
Feasibility of MR colonography with fecal tagging
Sensitivity/specificity of MR colonography versus colonoscopy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Suspicion of colorectal polyps or cancer
Referred for colonoscopy

Exclusion Criteria:

Suspicion of IBD
Pacemaker
Metal in the body
Claustrophobia
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael P Achiam, M.D.	Department of Radiology Copenhagen University Hospital Herlev	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Radiology Copenhagen University Hospital Herlev		Herlev		DK-2730	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms
D011127	Polyps

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided