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

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

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON47990
Enrollment
12
Registered
2019-04-26
Start date
2019-11-27
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

patients with a blood clot in one of the legs patients with deep venous thrombosis

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Adult subjects of either gender, aged 50 years or older, with a compression ultra-sound demonstrated acute DVT,

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
To assess the difference in uptake of 99mTc-Fucoidan in the affected vein versus the corresponding vein in the unaffected leg of patients with acute DVT.

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)