A proof-of-concept study to evaluate 99mTechnetium radiolabelled Fucoidan as diagnostic modality for thrombosis

Phase 2

Recruiting

• Conditions: patients with a blood clot in one of the legs; patients with deep venous thrombosis; 10014523

• Registration Number: NL-OMON47990
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

- Adult subjects of either gender, aged 50 years or older, with a compression ultra-sound demonstrated acute DVT, < 24 hours after treatment initiation
- BMI between 18 and 35 kg/m2

Exclusion Criteria

- Standard contra-indications to SPECT
- Any medical condition or treatment that could interfere with the conduct of the study in the opinion of the investigator
- Inability or unwilling to comply with protocol requirements, or deemed by the investigator to have a disorder that may compromise the ability to give informed consent

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the difference in uptake of 99mTc-Fucoidan in the affected vein<br /><br>versus the corresponding vein in the unaffected leg of patients with acute DVT.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess the effect of of Fucoidan on monocyte-endothelial and<br /><br>monocyte-platelet interaction in stimulated endothelium ex vivo </p><br>