NCT00188110

Brief Summary

The WE-CT is an innovative and easy practice imaging technique of colon tumors; it is based on the colon distension by a high volume of warm water and a multidetector CT acquisition after IV (intravenous) contrast, allowing image analysis including the wall thickness and enhancement, the pericolic adjacent spaces and the entire abdomen. The goal of the study is the evaluation of its performances for the diagnosis of colon tumors.

Trial Health

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Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

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

Study Start

First participant enrolled

March 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

January 9, 2007

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

January 8, 2007

Conditions

Colon Cancer

Keywords

Water-Enema Computed Tomographycolon tumorcoloscopysuspicion of colon tumorcoloscopy or surgery

Outcome Measures

Primary Outcomes (1)

  • To evaluate the performances of the WE-CT in patients suspected of having a colon tumor

Secondary Outcomes (2)

  • To show the CT findings in case of colon tumor and its pitfalls

  • To demonstrate the advantages of the WE-CT compared to the CT and magnetic resonance (MR) colonography for the diagnosis and local staging of colon tumors

Interventions

Water-Enema Computed TomographyPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Written informed consent
  • WE-TC indication for colon tumor suspicion
  • Age \> 18 years

You may not qualify if:

  • Pregnancy
  • Patients under 65 years old and for whom the only WE-TC indication is familial antecedents of colon tumor, without clinical or para-clinical personal signs for this pathology
  • Infected sigmoid diverticulosis
  • Occlusive syndrome
  • Anesthesia contraindications
  • Anal incontinence
  • Renal insufficiency (creatinine \> 150 micromol/L)
  • Iode allergy
  • Visceralgine contraindications
  • Scania contraindications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

UH of Angers

Angers, 49033, France

RECRUITING

UH of Besancon

Besançon, 25030, France

ACTIVE NOT RECRUITING

UH of Lyon

Lyon, 69003, France

RECRUITING

UH of Montpellier

Montpellier, 34295, France

ACTIVE NOT RECRUITING

UH of Rennes

Rennes, 35033, France

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Christophe Aube, MD

    UH of Angers

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christophe Aube, MD

CONTACT

00-2-41-35-42-76chaube@chu-angers.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

March 1, 2003

Last Updated

January 9, 2007

Record last verified: 2005-09

Locations

FR(5)