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
- Are there results?
- None posted in the registry
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.
Show all 11Show fewer
- 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.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02883140
- Acronym / sponsor ID
- PIGS / RC15_0196
- Conditions
- Non Tumor Salivary Gland Diseases of the Parotid Glands, Non Tumor Salivary Gland Diseases of the Submandibular Glands
- Keywords
- Sialography, Cone-beam CT, MRI sialography, non tumor salivary symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 23 Jun 2016 (actual)
- Primary completion
- 18 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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)
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three-dimensional sialography CBCT and MRI sialography1. 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 | Other | – |
Primary outcome
Detection of a salivary ductal disease with the 3D-CBCT sialography and the MRI sialography: Yes/No.
Time frame: 1 day
4 secondary outcomes
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)
Time frame: 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
Time frame: 1 day
Operational safety: Looking for adverse effects of the catheterization (pain, bleeding, ductal perforation)
Time frame: 1 day
Dose Area Product (mGy.cm-2) for 3D-CBCT sialography
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Derived from this study: PubMed 37420227Bertin 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.
- Individual participant dataSharing planned: Undecided. Not applicable now.
Related trials for Non Tumor Salivary Gland Diseases of the Parotid Glands
Recruiting
Swedish National Parotidectomy Study (SNaPs): Drainless Versus Standard Surgery
Parotid Neoplasms, Post-operative Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Delemazure Anne-Sophie, MD principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of a salivary ductal disease with the 3D-CBCT sialography and the MRI sialography: Yes/No. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02883140, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.