Clinical trial NCT05804474: A Retrospective, Multicenter, Controlled Clinical Trail: to Evaluate the Clinical Efficiency of Intracranial Aneurysm Assistive Software in the Morphological Measurement
Official title: A Retrospective, Multicenter, Controlled Clinical Trail: to Evaluate the Clinical Efficiency of Intracranial Aneurysm Assistive Software in the Morphological Measurement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Aneurysm
Keywords: Intracranial Aneurysm
Artificial Intelligence
Morphological measurement
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Wuxi No. 2 People's Hospital
name: RenJi Hospital
name: Shanxi Provincial People's Hospital
name: Beijing Chao Yang Hospital
name: Beijing Friendship Hospital
name: Guangzhou Red Cross Hospital
First posted: 2023-04-07
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese

Brief summary: the goal of this clinical trail is to evaluate the clinical efficiency of intracranial aneurysm assistive software in the morphological measurement. The trail is designed as retrospective, multicenter, controlled clinical trail. Collecting probable cases images retrospectively according to inclusion criteria and exclusion criteria strictly. Controlling bias strictly, to make sure the measurement of intracranial aneurysm assistive software is evaluated reliably and precisely. In our trail, six physicions were recruited, containing three neuroradiologists, two radiologists and a residents. Software-assistant planning controls against no software-assisant planning，which aims to evaluate the improvement of morphological measurement efficiency of physicians.


Eligibility criteria: Inclusion Criteria:

1. aged 18-75y, no gender limitation.
2. non-ruptured intracranial saccular aneurysm with specific intracranial CTA images.
3. Intracranial aneurysm was not treated.

Inclusion criteria of images:

1. the number of detector rows of Computed Tomography(CT) is more than 16 rows.
2. slice thickness ≤ 0.625mm, whole-brain image is considered.
3. Both plain scan sequences and enhancer sequence are required.

Exclusion Criteria:

1. combined with cerebral hemorrhage;
2. combined with cerevascular malformation or cerebral occupying lesion;
3. fusiform aneurysm or dissection aneurysm;
4. intracaverous internal carotid artery aneurysm;

Exclusion criteria of images:

1. none DICOM format;
2. quality score less than 3 scores;
3. metal artifacts existance.

Primary outcomes:
measure: Intracranial aneurysm size
timeFrame: 10 years
Secondary outcomes:
measure: Intracranial aneurysm volume
timeFrame: 10 years
measure: Intracranial aneurysm height
timeFrame: 10 years
measure: Intracranial aneurysm neck diameter
timeFrame: 10 years
measure: Parent artery diameter
timeFrame: 10 years
measure: Intracranial aneurysm width
timeFrame: 10 years
measure: Aspect ratio
timeFrame: 10 years
measure: Size ratio
timeFrame: 10 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
References: