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
France50 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 range
18 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Detection of a salivary ductal disease with the 3D-CBCT sialography and the MRI sialography: Yes/No.