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
|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|
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|
|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|
- Other: Three-dimensional sialography CBCT and MRI sialography
- 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
- Detection of a salivary ductal disease with the 3D-CBCT sialography and the MRI sialography: Yes/No. [ Time Frame: 1 day ]
- 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 ]
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
|Contact: Delemazure Anne-Sophie, MD||+332 40 08 41 firstname.lastname@example.org|
|Contact: CORRE Pierre, MD (surgeon)||+email@example.com|
|Principal Investigator:||Delemazure Anne-Sophie, MD||Nantes University Hospital|