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

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

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.

Study Overview

• Status: Completed
• Conditions: Non Tumor Salivary Gland Diseases of the Parotid Glands; Non Tumor Salivary Gland Diseases of the Submandibular Glands
• Intervention / Treatment: Other: Three-dimensional sialography CBCT and MRI sialography

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.

• Study Type: Observational
• Enrollment (Actual): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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)	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	1 day
Operational safety: Looking for adverse effects of the catheterization (pain, bleeding, ductal perforation)	1 day
Dose Area Product (mGy.cm-2) for 3D-CBCT sialography	1 day

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Delemazure Anne-Sophie, MD, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2016
• Primary Completion (Actual): August 18, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: May 10, 2016
• First Submitted That Met QC Criteria: August 24, 2016
• First Posted (Estimate): August 30, 2016

Study Record Updates

• Last Update Posted (Actual): September 8, 2022
• Last Update Submitted That Met QC Criteria: September 5, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Sialography; Cone-beam CT; MRI sialography; non tumor salivary symptoms
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases
• Other Study ID Numbers: RC15_0196

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Not applicable now.