Clinical Trial: Imaging Study of 3D-CBCT Sialography and MRI Sialography in Non Tumor Salivary Diseases

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: Prospective, Pilot, Comparative, Monocentric Study of Diagnosis Capabilities of the Three-dimensional Cone-Beam CT Sialography (3D-CBCT Sialography) and MRI Sialography in Non-tumor Salivary Diseases

Brief Summary: Non tumor salivary gland diseases are common and include sialadenitis, sialadenosis, stones, stricture and ductal dilatation, anatomical abnormalities. A radiological examination is required in order to sign the diagnosis, locate precisely the lesions and define the therapeutic strategy. Cone beam computerized tomography (CBCT), because of its accessibility and the possibilities it offers in terms of image processing, is a potential alternative to the conventional sialography and to the MRI sialography, considered as a gold standard procedure. Our comparative study, aims to evaluate the diagnostic performance of the 3D-CBCT sialography compared to MRI sialography, in patients with non tumor ductal salivary diseases.

Detailed Summary:

Our study focuses on patients over 18 years, with unilateral or bilateral parotid or submandibular salivary symptoms. Each patient included is given a MRI sialography and a 3D-CBCT sialography at a later stage when the acute episode has subsided. Images are archived on the Carestream Picture Archiving Communication System (PACS). Interpretation is achieved after Multi-Planar Reconstruction (MPR), Maximal Intensity Projection (MIP) and three-dimensional rendering. A primary radiological analysis of the two procedures is systematically done by a specialist radiologist for the diagnostic and therapeutic care of the patient. A second radiological data analysis is carried out at the end of the study, by a specialized radiologist, different from the first one, to asses the two radiological examinations.

The primary outcome measure is the capability of the radiological technique to detect a ductal salivary feature. Secondary outcomes include the clinical characteristics of the patients, the diagnostic capabilities in identifying the salivary lesions, their number, their precise location and measurements. A primary side effect in catheterization and dosimetric parameters for the CBCT technique will be systematically recorded.


Sponsor: Nantes University Hospital

Current Primary Outcome: Detection of a salivary ductal disease with the 3D-CBCT sialography and the MRI sialography: Yes/No. [ Time Frame: 1 day ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Precise location of lesions in the ductal system, identified as CSx for the Stensen's duct divisions and CWx for the Wharton's duct divisions (where CS1 and CW1 correspond to the main Stensen's and Wharton's ducts respectively) [ Time Frame: 1 day ]
  • Identification of the last salivary duct division visualized, identified as CSx for the Stensen's duct divisions and CWx for the Wharton's duct divisions [ Time Frame: 1 day ]
  • Operational safety: Looking for adverse effects of the catheterization (pain, bleeding, ductal perforation) [ Time Frame: 1 day ]
  • Dose Area Product (mGy.cm-2) for 3D-CBCT sialography [ Time Frame: 1 day ]


Original Secondary Outcome: Same as current

Information By: Nantes University Hospital

Dates:
Date Received: May 10, 2016
Date Started: September 2016
Date Completion: January 2018
Last Updated: August 24, 2016
Last Verified: August 2016