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

NCT ID: NCT02883140

Last Updated: 2022-09-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-23
• Study Completion Date: 2019-08-31

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.

Conditions

Non Tumor Salivary Gland Diseases of the Parotid Glands; Non Tumor Salivary Gland Diseases of the Submandibular Glands

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Three-dimensional sialography CBCT and MRI sialography

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Delemazure Anne-Sophie, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

References

Bertin H, Bonnet R, Le Thuaut A, Huon JF, Corre P, Frampas E, Langlois EM, Chesneau AD. A comparative study of three-dimensional cone-beam CT sialography and MR sialography for the detection of non-tumorous salivary pathologies. BMC Oral Health. 2023 Jul 8;23(1):463. doi: 10.1186/s12903-023-03159-9.

Reference Type: DERIVED

PMID: 37420227 (View on PubMed)

Other Identifiers

RC15_0196

Identifier Type: -

Identifier Source: org_study_id