Tokyo, Sept. 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063022) titled 'Effect of AI-based image reconstruction on quantitative values (ADC) and image quality in diffusion-weighted MRI' on Sept. 22.
Study Type:
Observational
Primary Sponsor:
Institute - University of Tsukuba
Condition:
Condition - Gynecological diseases (endometrial cancer, cervical cancer, ovarian cancer, etc.)
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To compare ADC values and image-quality metrics between conventional reconstruction and multiple acquisition and reconstruction conditions of pelvic diffusion-weighted imaging obtained within the same examination. The aims are to identify the range of conditions in which ADC values remain equivalent to conventional reconstruction, and to determine whether classification based on an established diagnostic cutoff of 0.9 x 10-3 mm2/s changes across reconstruction conditions.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Female
Key inclusion criteria - (1) Patients who underwent pelvic MRI on a 1.5-T or 3-T scanner at our institution for the workup of gynecological disease between study approval and March 2028. The standard clinical protocol includes diffusion-weighted imaging with multiple acquisition and reconstruction conditions. (2) Age 18 years or older. (3) Reconstruction data available for analysis.
Key exclusion criteria - Image quality judged inadequate for quantitative analysis because of severe motion or other causes.
Target Size - 60
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 08 Month 15 Day
Anticipated trial start date - 2026 Year 10 Month 01 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=R000072144
Disclaimer: Curated by HT Syndication.