MR Colonography With Fecal Tagging. Barium vs. BariumFeru... | NCT00332943

Studies
MR Colonography With Fecal Tagging. Barium vs. BariumFerumoxsil

NCT00332943

Sponsor

Herlev Hospital

Status

Completed

Last Update Posted

Sep 20, 2007Estimated

Enrollment

20Estimated

Phase

Phase 4

Conditions

Colorectal Cancer
Polyps

Interventions

MR colonography with fecal tagging

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
KA-20060039.

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

Dec 2005

Primary Completion Date

Not provided

Completion Date

May 2006Actual

First Submitted Date

Jun 1, 2006

First Submission Date that Met QC Criteria

Jun 1, 2006

First Posted Date

Jun 2, 2006Estimated

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 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).

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

20Estimated

Name	Type	Description	Arm Group Labels	Other Names
MR colonography with fecal tagging	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of fecal tagging agent
Sensitivity of VAS score vs. ReCon score

Secondary Outcomes

Not provided

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, MD	Department of Radiology Copenhagen University Hospital Herlev	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Radiology Copenhagen University Hospital Herlev		Copenhagen			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