Non Tumor Salivary Gland Diseases of the Parotid GlandsPIGSNCT02883140
Imaging Study of 3D-CBCT Sialography and MRI Sialography in Non Tumor Salivary Diseases
An observational study of Non Tumor Salivary Gland Diseases of the Parotid Glands and Non Tumor Salivary Gland Diseases of the Submandibular Glands, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Tumor Salivary Gland Diseases of the Parotid Glands, Non Tumor Salivary Gland Diseases of the Submandibular Glands
- What is being tested?
- Three-dimensional sialography CBCT and MRI sialography
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jun 2016to 31 Aug 2019
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Three-dimensional sialography CBCT and MRI sialography
- Keywords
- Sialography, Cone-beam CT, MRI sialography, non tumor salivary symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-dimensional sialography CBCT and MRI sialographyOther
- 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).
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of a salivary ductal disease with the 3D-CBCT sialography and the MRI sialography: Yes/No.
Measured: 1 day
Secondary outcomes (4)
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)
Measured: 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
Measured: 1 day
Operational safety: Looking for adverse effects of the catheterization (pain, bleeding, ductal perforation)
Measured: 1 day
Dose Area Product (mGy.cm-2) for 3D-CBCT sialography
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study start23 Jun 2016
- Primary completion18 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Tumor Salivary Gland Diseases of the Parotid GlandsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Delemazure Anne-Sophie, MD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883140
- Sponsor's protocol ID
- RC15_0196
- Acronym
- PIGS
- Status last verified
- Sep 2022
- First submitted
- 10 May 2016
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Not applicable now.
Publications
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.
PubMed 37420227