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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT01497457
First received: December 14, 2011
Last updated: December 19, 2011
Last verified: December 2011
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Interest of Saline MR Peritoneography for Pre-operative Assessment of Rectal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 20
Study Start Date: December 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Rectal adenocarcinoma

Exclusion Criteria:

  • Metastatic disease
  • under 18y patient
  • woman of childbearing age
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT01497457     History of Changes
Other Study ID Numbers: B403201112604
Study First Received: December 14, 2011
Last Updated: December 19, 2011
Health Authority: Belgium: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 18, 2013