3D Ultrasound in Hemophilic Ankles

NCT07452575 | Not Yet Recruiting

• 1 other identifier: 1000055523
• Study Type: interventional
• Target: 11
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study examines whether a mechanical arm ultrasound system provides diagnostic accuracy comparable to expert-performed full ultrasound for detecting key joint components and whether it can reduce acquisition variability without compromising accuracy, as measured by false-positive and false-negative rates.

Conditions

Hemophilia

Keywords

hemophilia; ultrasound; mechanical arm; children

Outcome Measures

Primary Outcomes (2)

• 1. Diagnostic Accuracy of 3DUS compared with full ultrasound and MRI

  Proportion of correctly classified cases comparing 3DUS findings against full ultrasoind and MRI (reference standard)

  Day 1

• Ability of 3DUS to quantify individual joint components (synovial hypertrophy, hemarthrosis, hemosiderin, bone erosions/subchondral cysts, cartilage loss)

  Findings will be measured as normal, mild, moderate and severe

  Day 1

Secondary Outcomes (1)

• Integration of 3D ultrasound into Diagnostic Algorithm

  Day 1

Other Outcomes (1)

• Feasibility and Image Quality of 3D ultrasound

  Day 1

Study Arms (1)

Hemophilic Participant

EXPERIMENTAL

Participants will undergo a 3D ultrasound of an ankle joint performed by a mechanical arm (intervention), a standard ultrasound, and an MRI of the study joint for comparison.

Device: Mechanical Ultrasound

Interventions

Mechanical Ultrasound DEVICE

3D ultrasound imaging is a non-invasive technique. The device consists of a stationary platform and a water-filled rotating drum designed to acquire 3D ultrasound images of the ankles. An ultrasound transducer is mounted on a mechanical arm, which positions and orients it toward the rotating axis of the drum. The collected ultrasound images will be mapped into 3D space, and the volume will be reconstructed using software developed by the manufacturer.

Hemophilic Participant

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of hemophilia A or B or other bleeding disorders
• Cooperative patients
• Previous study joint bleed (by history) or suspicion of an acute joint bleed

You may not qualify if:

• Co-morbid chronic illnesses causing osteoarticular findings
• MRI contraindications

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Western University, Canada: collaborator

Related Publications (2)

• Rascevska E, Tessier DR, Doria AS, Fenster A. Proof-of-Concept Study of a 3-D Ultrasound Scanner Used for Ankle Joint Assessment. Ultrasound Med Biol. 2023 Jan;49(1):278-288. doi: 10.1016/j.ultrasmedbio.2022.09.002. Epub 2022 Oct 8.

  PMID: 36220709 BACKGROUND

• Fenster A, Downey DB, Cardinal HN. Three-dimensional ultrasound imaging. Phys Med Biol. 2001 May;46(5):R67-99. doi: 10.1088/0031-9155/46/5/201.

  PMID: 11384074 BACKGROUND

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Principal Investigator

CONTACT

+416-813-6079; andrea.doria@sickkids.ca

Clinical Research Project Manager

CONTACT

+416-813-7654

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiologist

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 5, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 1 month and ending 3 years after the publication of results
• Access Criteria: De-identified individual participant data (IPD) from this study will be made available to qualified researchers conducting independent, scientifically valid research, contingent upon obtaining any required approvals from an Institutional Review Board (IRB). Eligible researchers may access de-identified, coded participant-level data with no personal health information, along with supporting study documents. Access will occur through a controlled process in which researchers must submit a formal data request, and data-sharing agreements may be executed when needed.