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

Nantes University Hospital50 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Non Tumor Salivary Gland Diseases of the Parotid Glands

Interventions

Three-dimensional sialography CBCT and MRI sialographyOTHER

1. MRI sialography: Achieved on a 3 Tesla MRI (INGENA 3T Philips Medical Systems). Patient supine positioned. Sialo-MR sequences (3D T2 DRIVE, TSE, SENSE and SPIR) and conventional sequences (T2 turbo spin echo). 2. 3D CBCT sialography: Achieved same day as the MRI sialography, after acute episode subsided. 0.5ml of high concentration, water-soluble, iodinated contrast product (HEXABRIX 320®, 320g /L, Guerbet, France) is injected in the symptomatic salivary gland and maintained in the gland. Image acquisition performed on a wide-field CBCT device (NewTom VGi, QR, Verona, Italy). Front and profile scout views achieved. mA and exposure time modulated according to scout views. Reconstruction in Maximal Intensity Projection, 3-dimensional and MultiPlanar Reconstructions sections

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female, over 18 years old. * With unilateral or bilateral parotid or submandibular salivary symptoms (salivary swelling, salivary colic, pain, salivary infections), with an acute evolution (\<14 days), subacute (2-12 weeks) or chronic one (\>3 months). * With or without initial imaging (ultrasonography). * Understanding the technique and its interest in the diagnostic and therapeutic management. * Accepting the examination and the salivary catheterization. * Positive catheterization test Exclusion Criteria: * Patient whose physical or mental condition make him unable to understand the examination and to consent to the study. * Allergy to iodine. * Salivary infection under treatment. * Damage to the oral mucosa preventing salivary catheterization. * Contraindication to MRI: metal or valvular prosthesis, pacemaker, claustrophobia. * Current or suspected pregnancy. * Patient refusing the examination or the catheterization. * Salivary symptoms of tumor appearance: Unilateral palpable mass, facial palsy, multiple lymph nodes in parotid and / or pre-auricular and / or neck areas. * Salivary neoplasm demonstrated by a prior diagnostic testing. * Patient who underwent head and neck scan in the previous 6 months. Conventional or three dimensional sialography achieved in the previous 6 months. * Salivary catheterization failure.

Outcomes

Primary Outcomes

Detection of a salivary ductal disease with the 3D-CBCT sialography and the MRI sialography: Yes/No.

Time frame: 1 day

Secondary Outcomes

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