Clinical trial · Observational
Imaging Study of 3D-CBCT Sialography and MRI Sialography in Non Tumor Salivary Diseases
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Tumor Salivary Gland Diseases of the Parotid Glands | — | UNRESOLVED | — |
| Non Tumor Salivary Gland Diseases of the Submandibular Glands | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Three-dimensional sialography CBCT and MRI sialography | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Detection of a salivary ductal disease with the 3D-CBCT sialography and the MRI sialography: Yes/No.
- timeFrame
- 1 day
Secondary outcomes (4)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDBertin 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. PMID 37420227