Clinical trial NCT02883140: Imaging Study of 3D-CBCT Sialography and MRI Sialography in Non Tumor Salivary Diseases
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Tumor Salivary Gland Diseases of the Parotid Glands
Non Tumor Salivary Gland Diseases of the Submandibular Glands
Keywords: Sialography
Cone-beam CT
MRI sialography
non tumor salivary symptoms
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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)

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Detection of a salivary ductal disease with the 3D-CBCT sialography and the MRI sialography: Yes/No.
timeFrame: 1 day
Secondary outcomes:
measure: 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)
timeFrame: 1 day
measure: 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
timeFrame: 1 day
measure: Operational safety: Looking for adverse effects of the catheterization (pain, bleeding, ductal perforation)
timeFrame: 1 day
measure: Dose Area Product (mGy.cm-2) for 3D-CBCT sialography
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Nantes University Hospital
name: Delemazure Anne-Sophie, MD
role: PRINCIPAL_INVESTIGATOR
References: