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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26785
Enrollment
12
Registered
2019-02-04
Start date
2019-06-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep vein thrombosis

Interventions

99mTc-Fucoidan SPECT/CT imaging

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The difference in uptake value of 99mTc-Fucoidan in the affected vein versus the corresponding vein in the unaffected leg of patients with an acute DVT

Secondary

MeasureTime frame
To assess the effect of of Fucoidan on monocyte–endothelial and monocyte-platelet interaction in stimulated endothelium ex vivo

Contacts

Public ContactYannick Kaiser

Amsterdam University Medical Centers, location AMC

y.kaiser@amsterdamumc.nl0205668675

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)