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

NCT02883140 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2022-09-08

No results posted yet for this study

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.

Conditions

  • Non Tumor Salivary Gland Diseases of the Parotid Glands
  • Non Tumor Salivary Gland Diseases of the Submandibular Glands

Interventions

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

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Delemazure Anne-Sophie, MD · Nantes University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-23
Primary Completion
2019-08-18
Completion
2019-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02883140 on ClinicalTrials.gov