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Imaging Study of 3D-CBCT Sialography and MRI Sialography in Non Tumor Salivary Diseases (PIGS)

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ClinicalTrials.gov Identifier: NCT02883140
Recruitment Status : Unknown
Verified August 2016 by Nantes University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 30, 2016
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief 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.

Condition or disease Intervention/treatment
Non Tumor Salivary Gland Diseases of the Parotid Glands Non Tumor Salivary Gland Diseases of the Submandibular Glands Other: Three-dimensional sialography CBCT and MRI sialography

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 Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Study Start Date : September 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Three-dimensional sialography CBCT and MRI sialography
    1. 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


Primary Outcome Measures :
  1. Detection of a salivary ductal disease with the 3D-CBCT sialography and the MRI sialography: Yes/No. [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Operational safety: Looking for adverse effects of the catheterization (pain, bleeding, ductal perforation) [ Time Frame: 1 day ]
  4. Dose Area Product (mGy.cm-2) for 3D-CBCT sialography [ Time Frame: 1 day ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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)
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02883140


Contacts
Contact: Delemazure Anne-Sophie, MD +332 40 08 41 19 annesophie.delemazure@chu-nantes.fr
Contact: CORRE Pierre, MD (surgeon) +332.40.08.36.75 pierre.corre@chu-nantes.fr

Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Delemazure Anne-Sophie, MD Nantes University Hospital

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02883140     History of Changes
Other Study ID Numbers: RC15_0196
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Not applicable now.

Keywords provided by Nantes University Hospital:
Sialography
Cone-beam CT
MRI sialography
non tumor salivary symptoms

Additional relevant MeSH terms:
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases