No registrations found.
ID
Source
Brief title
Health condition
Fucoidan; P-selectin; cardiovascular disease; atherosclerosis; thrombosis
Sponsors and support
Intervention
Outcome measures
Primary outcome
Tolerability will be evaluated on the frequency and severity of adverse events, as well as on the following parameters:
- Vital signs
- Physical examination
- ECG
- Clinical blood laboratory measurements
Secondary outcome
- Biodistribution (blood clearance and tissue biodistribution)
- Dosimetry (effective dose in mSv per organ and per individual determined from biodistribution)
Background summary
The development of an innovative imaging agent capable of non-invasively detecting
vulnerable plaques is a major goal of research in cardiovascular pathology. Such a tool
would allow better identification of patients at risk for acute cardiovascular events. We have
shown that 99mTechnetium-labeled (99mTc) Fucoidan can target P-selectin expressed by in
vitro activated human platelets and in vivo in an animal model of aortic thrombosis as well as
endocarditis. One of the objectives of the Nanoathero program is the clinical translation of
99mTc-Fucoidan scintigraphy. First, we will study the tolerability and the dosimetric evaluation
of this new radiopharmaceutical in humans.
Study objective
The development of an innovative imaging agent capable of non-invasively detecting vulnerable plaques is a major goal of research in cardiovascular pathology. Such a tool would allow better identification of patients at risk for acute cardiovascular events. We have shown that 99mTechnetium-labeled (99mTc) Fucoidan can target P-selectin expressed by in vitro activated human platelets and in vivo in an animal model of aortic thrombosis as well as endocarditis. One of the objectives of the Nanoathero program is the clinical translation of 99mTc-Fucoidan scintigraphy. First, we will study the tolerability and the dosimetric evaluation of this new radiopharmaceutical in humans.
Study design
After injection of 99mTc-Fucoidan, t=30min, 1.5h, 3h, 6h, 24h and 7d
Intervention
99mTc-Fucoidan SPECT/CT
K.H. Zheng
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 20 5667516
k.h.zheng@amc.nl
K.H. Zheng
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 20 5667516
k.h.zheng@amc.nl
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Adult subjects of either gender, aged 18 years or older
- BMI between 18 and 35 kg/m2
- Effective contraception in women of childbearing age
- Use of effective contraception in men for 24 hours after injection of 99mTc-Fucoidan
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Progressive and chronic disease
- Chronic infection with HIV, HBV or HCV
- Clinically significant abnormalities during screening
- Pregnancy or breast-feeding
- Active medication use or previous long-term intake of medication
- Any other treatment that could interfere with the conduct or interpretation of the study in the opinion of the investigator
- Any other clinically relevant condition that could interfere with the conduct of the study in the opinion of the investigator
- Standard contra-indications to SPECT/CT
- 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6703 |
| NTR-old | NTR6873 |
| Other | METC AMC Amsterdam : 2017_321 |