Tokyo, Feb. 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060736) titled 'Development of MR Cine Sialography for the Evaluation of Salivary Gland Function' on Feb. 23.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Juntendo University

Condition: Condition - Sjogren's syndrome,Salivary gland dysfunction, Volunteers Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to perform MR cine sialography (MRCS) using the Time-Spatial Labeling Inversion Pulse (Time-SLIP) technique to simultaneously visualize the bilateral salivary glands and depict salivary flow from both the submandibular and parotid glands, and to evaluate salivary gland function and its clinical utility. Basic objectives2 - Bio-equivalence

Intervention: Interventions/Control_1 - MRI will be used to noninvasively visualize salivary flow without contrast agents. The examination will be performed once, with a total scan time of approximately 30 minutes. During the examination, citric acid will be administered into the oral cavity using an injector.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - Healthy volunteers; patients with reduced salivary secretion; patients with Sjogren's syndrome; and patients with head and neck malignancies before and after radiotherapy. Key exclusion criteria - Individuals with MRI-incompatible metallic implants; individuals with severe claustrophobia; and individuals who request discontinuation of the examination. Target Size - 120

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 05 Month 19 Day Date of IRB - 2025 Year 05 Month 19 Day Anticipated trial start date - 2025 Year 05 Month 19 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069485

Disclaimer: Curated by HT Syndication.