Radiomics of Autism Spectrum Disorder

Autism Spectrum Disorder Clinical Trial

Official title:

Application of MRI Radiomics to Improve Diagnosis and Pharmacologica Prognosis of Autism Spectrum Disorder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05439954
• Other study ID #: QL Chen
• Status: Active, not recruiting
• Start date: January 1, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2024
• Source: Fifth Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Autism Spectrum Disorder (ASD) refers to a group of neurodevelopmental disorders including autism.Despite ongoing studies, the pathogenesis of ASD still remains unclear.The global prevalence of ASD was estimated at 1% in 2015.The diagnostic criteria for ASD are specified in the DSM ( American Psychiatric Association, 2013 ) and serve as guideline for clinicians at the present. However, its early diagnosis value is limited due to a high subjectivities and its low diagnostic sensitivity and specificity.Early detection and early pharmacological and behavioral interventions are critical in improving the symptoms and preventing the disease progression. There are no medications that directly treat the core symptoms present in individuals with ASD, and the effectiveness of interventions remains limited. Therefore, accurate assessment of pharmacological efficacy is necessary for the reatment, and prognostication of individuals with ASD. Magnetic resonance imaging (MRI) is a commonly used imaging tool for clinical disease diagnosis, especially for neurological disorders. Besides, Structural Magnetic Resonance imaging reflects neuropathological and microstructural developmental changes during growth. Radiomics based on the high-dimensional quantitation of medical images, allowing extraction of more detailed characteristics than is possible with conventional visual interpretation. This study aims: (1)To explore an objective diagnostic method through radiomics in children with ASD (2)to provide prognostic estimates of the outcome, based on estimates of an individual patient's prognosis and the efficacy of different drug therapies.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 230
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 14 Years

Eligibility

Inclusion Criteria:(a)healthy subject of same ages;(b)without injury to head and diseases of the nervous system; (c)without family history of mental disorders; (d)without other somatic illness.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Locations

Country	Name	City	State
China	The Fifth Affiliated Hospital at Sun Yat-sen University	Zhuhai	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Qingling Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnosis of autism spectrum disorder	differential diagnosis of case group and control group	01/12/2022