Preoperative Assessment of Colon Tumor | NCT00114829

Studies
Preoperative Assessment of Colon Tumor

NCT00114829

Sponsor

Herlev Hospital

Status

Unknown status

Last Update Posted

Mar 9, 2006Estimated

Enrollment

Phase

Phase 4

Conditions

Colorectal Cancer
Colorectal Tumor

Interventions

MR colonography with dynamic contrast uptake

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
KA05028

Status Module

Record Verification Date

May 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Not provided

Completion Date

Not provided

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

Mar 8, 2006

Last Update Posted Date

Mar 9, 2006Estimated

Name	Class
University Hospital, Gentofte, Copenhagen	OTHER

Description Module

Brief Summary

The purpose of this study is to determine whether a colonic tumor can be classified as malignant or benign with magnetic resonance (MR) colonography. Patients with a verified colon carcinoma or benign tumor based on diverticulitis are offered a MR colonography with intravenous (I.V.) contrast. The tumor is classified as malignant or benign by assessing the dynamic contrast uptake and morphology. The Investigator is blinded from the verified diagnosis and the MR classification is compared to the histological diagnosis.

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

Name	Type	Description	Arm Group Labels	Other Names
MR colonography with dynamic contrast uptake	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity in determining malignant or benign diagnose

Secondary Outcomes

Measure	Description	Time Frame
Sensitivity/specificity of MR colonography

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Colorectal cancer
Colorectal tumor

Exclusion Criteria:

Active diverticulitis
Pacemaker
Metal in the body
Claustrophobia

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

Name	Role	Phone	Extension	Email
Michael P Achiam, M.D	Contact	+45 44884391		achiam1@dadlnet.dk

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	Recruiting	Herlev		Dk-.2730	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19419830	Derived	Achiam MP, Andersen LP, Klein M, Logager V, Chabanova E, Thomsen HS, Rosenberg J. Differentiation between benign and malignant colon tumors using fast dynamic gadolinium-enhanced MR colonography; a feasibility study. Eur J Radiol. 2010 Jun;74(3):e45-50. doi: 10.1016/j.ejrad.2009.03.033. Epub 2009 May 5.

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