NCT01497457

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 22, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

1.8 years

First QC Date

December 14, 2011

Last Update Submit

May 19, 2015

Conditions

Rectal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • 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: 1. Visualisation of the Douglas 2. Visualisation of the Tumor 3. Determination of the distance between the tumor and the pouch of Douglas

    Two years

Study Arms (1)

MR saline peritoneography

EXPERIMENTAL

Patients that will undergo MR saline peritoneography

Procedure: MR saline peritoneography

Interventions

MR saline peritoneographyPROCEDURE

Ultrasound-guided Intraperitoneal injection of 250cc of steril saline solution with a 22G needle, followed by rectal MR imaging

MR saline peritoneography

Eligibility Criteria

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

You may qualify if:

  • Rectal adenocarcinoma

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires St Luc - Université Catholique de Louvain

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Cristina A Dragean, MD

    Cliniques Universitaires St Luc - Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2011

First Posted

December 22, 2011

Study Start

December 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

May 20, 2015

Record last verified: 2015-05

Locations

BE(1)