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Interest of Saline MR Peritoneography for Pre-operative Assessment of Rectal Cancer

Primary Purpose

Rectal Adenocarcinoma

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
MR saline peritoneography
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Rectal Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Rectal adenocarcinoma

Exclusion Criteria:

  • Metastatic disease
  • under 18y patient
  • woman of childbearing age

Sites / Locations

  • Cliniques Universitaires St Luc - Université Catholique de Louvain

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MR saline peritoneography

Arm Description

Patients that will undergo MR saline peritoneography

Outcomes

Primary Outcome Measures

Determination of the distance between a rectal tumor and the pouch of Douglas
Feasability of the determination of the distance between a rectal tumor and the pouch of Douglas by MR saline peritoneography: Visualisation of the Douglas Visualisation of the Tumor Determination of the distance between the tumor and the pouch of Douglas

Secondary Outcome Measures

Full Information

First Posted
December 14, 2011
Last Updated
May 19, 2015
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT01497457
Brief Title
Interest of Saline MR Peritoneography for Pre-operative Assessment of Rectal Cancer
Official Title
Interest of Saline MR Peritoneography for Pre-operative Assessment of Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
MR saline peritoneography could be useful to demonstrate the peritoneal outline of the pouch of Douglas. The investigators think that the localization of the rectal tumor in function of this anatomic mark could be decisive for pre-operative assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Adenocarcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MR saline peritoneography
Arm Type
Experimental
Arm Description
Patients that will undergo MR saline peritoneography
Intervention Type
Procedure
Intervention Name(s)
MR saline peritoneography
Intervention Description
Ultrasound-guided Intraperitoneal injection of 250cc of steril saline solution with a 22G needle, followed by rectal MR imaging
Primary Outcome Measure Information:
Title
Determination of the distance between a rectal tumor and the pouch of Douglas
Description
Feasability of the determination of the distance between a rectal tumor and the pouch of Douglas by MR saline peritoneography: Visualisation of the Douglas Visualisation of the Tumor Determination of the distance between the tumor and the pouch of Douglas
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Rectal adenocarcinoma Exclusion Criteria: Metastatic disease under 18y patient woman of childbearing age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristina A Dragean, MD
Organizational Affiliation
Cliniques Universitaires St Luc - Université Catholique de Louvain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques Universitaires St Luc - Université Catholique de Louvain
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

Interest of Saline MR Peritoneography for Pre-operative Assessment of Rectal Cancer

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