Imaging Study of 3D-CBCT Sialography and MRI Sialography in Non Tumor Salivary Diseases (NCT02883140) | Clinical Trial Compass
CompletedNot Applicable
Imaging Study of 3D-CBCT Sialography and MRI Sialography in Non Tumor Salivary Diseases
50 participantsStarted 2016-06-23
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Detection of a salivary ductal disease with the 3D-CBCT sialography and the MRI sialography: Yes/No.