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

Phase 1

Conditions: Deep vein thrombosis
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Registration Number: EUCTR2019-000133-39-NL

Lead Sponsor: Academic Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

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: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: t = 90m after injection of 99mTc-Fucoidan;Main Objective: To determine the uptake of 99mTc-Fucoidan in a fresh thrombus of patients with acute deep vein thrombosis (DVT).;Secondary Objective: To assess monocyte-endothelial interactions and platelet-monocyte interactions in vitro before and after Fucoidan;Primary end point(s): 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 Outcome Measures

Name	Time	Method
Secondary end point(s): To assess the effect of of Fucoidan on monocyte–endothelial and monocyte-platelet interaction in stimulated endothelium ex vivo <br>;Timepoint(s) of evaluation of this end point: First blood withdrawal