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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01497457
First Posted: December 22, 2011
Last Update Posted: May 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  Purpose
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.

Condition Intervention
Rectal Adenocarcinoma Procedure: MR saline peritoneography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Interest of Saline MR Peritoneography for Pre-operative Assessment of Rectal Cancer

Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:
  • Determination of the distance between a rectal tumor and the pouch of Douglas [ Time Frame: Two years ]

    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


Enrollment: 17
Study Start Date: December 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MR saline peritoneography
Patients that will undergo MR saline peritoneography
Procedure: MR saline peritoneography
Ultrasound-guided Intraperitoneal injection of 250cc of steril saline solution with a 22G needle, followed by rectal MR imaging

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Rectal adenocarcinoma

Exclusion Criteria:

  • Metastatic disease
  • under 18y patient
  • woman of childbearing age
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01497457


Locations
Belgium
Cliniques Universitaires St Luc - Université Catholique de Louvain
Bruxelles, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Principal Investigator: Cristina A Dragean, MD Cliniques Universitaires St Luc - Université Catholique de Louvain
  More Information

Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT01497457     History of Changes
Other Study ID Numbers: B403201112604
First Submitted: December 14, 2011
First Posted: December 22, 2011
Last Update Posted: May 20, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Adenocarcinoma
Rectal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases