A Multi-center Cohort Study for Conventional Ultrasound Image Set Collection to Create a Training Data Set for Research Purposes (Image Processing and Analysis, AI Model Training).

Status: Recruiting
Location: See all (5) locations...
Study Type: Observational
SUMMARY

This study aims to collect and create a labelled ultrasound image data set containing ultrasound image series and video clips of patients that undergo routine ultrasound scans on lower limbs, because of suspected deep vein thrombosis. The data will be used to train an AI model within ThrombUS+ project to achieve automated detection of deep vein thrombosis on conventional ultrasound scans. Primary objectives: 1. Collect and curate imaging data from ultrasound scans of patients suspected for DVT. 2. Collect accompanying metadata on patient demographics, referral note, existing known medical conditions at the time of scan, diagnosis based on the scan, operator anonymized ID, metadata on the ultrasound equipment used. 3. Anonymize the data set according to established regulations to be used for research purposes and in specific for training an artificial intelligence model to achieve automated DVT detection. Secondary objectives: 1\. Describe the data set in the Argos/OpenAIRE tool and make it publicly available through the European Open Science Cloud (EOSC) portal via OpenAIRE, to be used by other researchers for image processing, analysis, and artificial intelligence (AI) model training.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years.

• The participant has the capacity to consent, and consent is obtained prior to any study-specific procedures.

• The conventional diagnostic DVT algorithm indicates that an ultrasound is needed, or the patient has been referred for a scan on suspicion of DVT.

Locations
Other Locations
France
Groupement Hospitalier Eaubonne Montmorency Simone Veil
RECRUITING
Montmorency
Greece
University General Hospital of Alexandroupoli
RECRUITING
Alexandroupoli
Papageorgiou General Hospital
RECRUITING
Thessaloniki
Italy
Home Relief of Suffering Hospital
RECRUITING
San Giovanni Rotondo
Lithuania
Lithuanian University of Health Science
RECRUITING
Kaunas
Contact Information
Primary
Eleni Kaldoudi, Prof.
kaldoudi@athenarc.gr
+306937124358
Backup
Stelios Didaskalou, Dr.
stelios.didaskalou@athenarc.gr
+30 697 163 5361
Time Frame
Start Date: 2024-11-06
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 3000
Treatments
Patients with suspected DVT referred for a DVT ultrasound scan.
Patients with suspected DVT referred for a DVT ultrasound scan will be consecutively selected to account for demographics, medical condition and ultrasound operator diversity in the sample; data selected will be anonymized and included in the data set.~In and out-patients referred for an ultrasound scan for suspected DVT will be asked to participate (informed consent process).
Sponsors
Leads: ThrombUS+

This content was sourced from clinicaltrials.gov