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

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
• Overall Status: Completed
• CT.gov ID: NCT01497457
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arm: 1
• Duration (Months): 21
• Patients Per Site Per Month: 0.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Adenocarcinoma	Procedure: MR saline peritoneography	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: N/A
• 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
• Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Determination of the distance between a rectal tumor and the pouch of Douglas [Two years]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Rectal adenocarcinoma

Exclusion Criteria:

• Metastatic disease

• under 18y patient

• woman of childbearing age

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• ClinicalTrials.gov Identifier: NCT01497457
• Other Study ID Numbers: B403201112604
• First Posted: Dec 22, 2011
• Last Update Posted: May 20, 2015
• Last Verified: May 1, 2015

• Additional relevant MeSH terms: Adenocarcinoma; Rectal Neoplasms

Study Results

No Results Posted as of May 20, 2015