Radiological study for vascular anomalies using AI

JRCT ID: jRCT1040220052

Registered date:11/08/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Vascular anomalies
• Date of first enrollment: 11/08/2022
• Target sample size: 20
• Study type: Observational

Outcome(s)

• Primary Outcome: Correlation coefficient between "lesion volume of vascular abnormalities measured by deep learning" and "lesion volume independently measured by two radiologists"

Secondary Outcome

Correlation coefficient (ICC(2,1)) of analysis results of area and volume measured independently by two radiologists and a trained doctor
Differences in AI segmentation and correlation coefficients with different MRI images (fat-suppressed T2-weighted images, T1-weighted images, contrast-enhanced T1-weighted images, etc.)

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

1, A multicenter phase III investigator-initiated clinical trial (NPC-12T-LM study) conducted from 2017 to 2019 to investigate the efficacy and safety of NPC-12T (sirolimus) for intractable lymphatic disease, Multi-center, open-label, uncontrolled study to investigate the safety and efficacy of sirolimus for refractory vascular and lymphatic diseases (SRL-CVA-01 study, jRCTs031180290) started in 2017, and Conducted from 2020 to 2022, a multicenter phase III investigator-initiated clinical trial (NPC -12T-CVA)
2) Patients with evaluable MRI images
3) Patients who agreed to participate in this study

Exclude criteria

1) Patients with other than obvious vascular abnormalities
2) Patients with clearly different lesions and image artifacts such as bleeding and inflammation that are difficult to evaluate
3) Other patients who are judged to be inappropriate by the principal investigator or co-investigator

Related Information

• Primary Sponsor: Michio Ozeki
• Secondary Sponsor: AMED