Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02883140 |
| Other study ID # |
RC15_0196 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 23, 2016 |
| Est. completion date |
August 31, 2019 |
Study information
| Verified date |
September 2022 |
| Source |
Nantes University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
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.
