Ireland
--:--IST
Recruiting Observational

A Multi-center Cohort Study for Conventional Ultrasound Image Set Collection to Create a Data Set for Research Purposes.

NCT06989255 · tracked via the Priya Life Science Italy tracker
Sponsor
ThrombUS+
Phase
Observational
Started
2024-11-06
Last updated
2025-05-25

Condition(s) studied

Deep Vein Thrombosis

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * Patients with a known condition or reason that may potentially result in interrupting or stopping the ultrasound examination before its completion. * Patients considered by their treating physician or the ultrasound operator as non-suitable for a standard ultrasound scan. * Patients who have not signed the informed consent.

Primary outcome measure(s)

  • Ultrasound data — Day 1
    The data set will include negative scans, positive for deep vein thrombosis scans, positive for other diagnosis scans and scans of insufficient quality to aid towards diagnosis, together with imaging metadata and a set of labels for each scan.

Trial sites (5)

FacilityCityRegionStatus
Groupement Hospitalier Eaubonne Montmorency Simone Veil Montmorency France Recruiting
University General Hospital of Alexandroupoli Alexandroupoli Greece Recruiting
Papageorgiou General Hospital Thessaloniki Greece Recruiting
Home Relief of Suffering Hospital San Giovanni Rotondo Italy Recruiting
Lithuanian University of Health Science Kaunas Lithuania Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06989255 on ClinicalTrials.gov ↗ ← All trials in Italy