Preoperative Assessment for Synchronous Carcinoma or Poly... | NCT00300547

Studies
Preoperative Assessment for Synchronous Carcinoma or Polyps With Magnetic Resonance (MR) Colonography

NCT00300547

Sponsor

Herlev Hospital

Status

Completed

Last Update Posted

Aug 18, 2010Estimated

Enrollment

50Actual

Phase

Phase 4

Conditions

Obstructing Colorectal Cancer

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
KA05030

Status Module

Record Verification Date

Mar 2006

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 2007

Primary Completion Date

Apr 2008Actual

Completion Date

Not provided

First Submitted Date

Mar 8, 2006

First Submission Date that Met QC Criteria

Mar 8, 2006

First Posted Date

Mar 9, 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

Aug 17, 2010

Last Update Posted Date

Aug 18, 2010Estimated

Name	Class
University Hospital, Gentofte, Copenhagen	OTHER

Description Module

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.

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

50Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MR colonography	Procedure	Altered planned surgical procedure if MR colonoscopy reveals synchronous cancer or larger polyps

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Feasibility of MR colonography to diagnose possible synchronous carcinomas and polyps		3

Secondary Outcomes

Measure	Description	Time Frame
Altered operative strategy due to findings on MR colonography		3

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Obstructing colorectal cancer

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		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