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EnteroCT With Enteroclysis Versus Enterography-MRI for the Diagnosis of Tumors of the Small Intestine: a Pilot Study (enteroMRI-TSI)

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ClinicalTrials.gov Identifier: NCT02872623
Recruitment Status : Unknown
Verified August 2016 by CHU de Reims.
Recruitment status was:  Recruiting
First Posted : August 19, 2016
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Brief Summary:

Early diagnosis of tumors of the small intestine is a challenge for clinicians and for radiologists. The detection of tumors of the small intestine is a field in which the video capsule endoscopy has the lowest performance.

The entero-CT with enteroclysis is the imaging technique used primarily to explore patients with a strong suspicion of small intestine tumors. However the entero-CT with enteroclysis has disadvantages : it is irradiating, the nasojejunal tube implies a discomfort to the patient and it is a complicated examination in terms of logistics with necessity of specific equipment to insert the nasojejunal tube.

MRI has been proposed as an alternative imaging technique and satisfactory results have been reported with the MRI enteroclysis. However, this technique has several disadvantages related to nasojejunal tube insertion and the necessity of equipment compatible with the high magnetic fields. The enterography-MRI without enteroclysis, whose principle is to distend the small intestine by ingestion of large quantities of a liquid, has a major and undisputed role in the exploration of Crohn's disease of the small bowel. However, its capacity for distension of the small intestine for optimal tumor detection is questioned and its role in tumor detection is largely unknown.


Condition or disease Intervention/treatment Phase
Suspicion of Tumor of the Small Intestine Radiation: Enterography-MRI without enteroclysis Radiation: enteroCT with enteroclysis Not Applicable

Detailed Description:
Evaluate the diagnostic performances of enteroCT with enteroclysis and enterography-MRI without enteroclysis, for the diagnosis of tumor of the small intestine, among patients with suspicion of small intestine tumors.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: EnteroCT With Enteroclysis Versus Enterography-MRI for the Diagnosis of Tumors of the Small Intestine: a Pilot Study
Study Start Date : March 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : September 2018

Arm Intervention/treatment
Experimental: experimental group
patients clinically suspected of having a tumor of the small intestine
Radiation: Enterography-MRI without enteroclysis
Radiation: enteroCT with enteroclysis



Primary Outcome Measures :
  1. Presence of a tumor of the small intestine [ Time Frame: 12 months ]
    Presence of a tumor of the small intestine diagnosed using pathological results or using clinical evaluation at 12 months (if no biopsy is performed).



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

Inclusion Criteria:

  • patient clinically suspected of having a tumor of the small intestine
  • patient consenting to participate to the study
  • patient enrolled in the national healthcare insurance program
  • patient older than 18 years

Exclusion Criteria:

  • patient with inflammatory bowel disease
  • patient with contraindication for MRI

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): NCT02872623


Contacts
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Contact: Alban COLOSIO acolosio@chu-reims.fr

Locations
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France
Chu de Reims Recruiting
Reims, France, 51092
Contact: Alban COLOSIO       acolosio@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims

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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT02872623     History of Changes
Other Study ID Numbers: PO14065
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016