To evaluate the tolerability (adverse effects) of 99mTc-Fucoidan in 10 healthy volunteers (phase I).
ID
Source
Brief title
Condition
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is tolerability based on the following: adverse events,
vital signs, clinical examination, ECG, clinical laboratory measurements.
Secondary outcome
The secondary objectives are to determine:
1. Biodistribution (blood clearance, tissue distribution)
2. 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
To evaluate the tolerability (adverse effects) of 99mTc-Fucoidan in 10 healthy
volunteers (phase I).
Study design
A single-center, interventional, open, nonrandomized, safety assessment (phase
I) of a new diagnostic imaging technique in 10 healthy volunteers.
Study burden and risks
The development of an innovative imaging agent capable of non-invasively
detecting vulnerable plaques is a major objective of research in cardiovascular
pathology. Such a tool would improve identification of high-risk patients,
allowing for initation or intensification of treatment.
In the present study, participating subjects receive no direct or immediate
benefits. The burden and risk of participating in this study is estimated to be
low. Patients will visit the clinical trial unit 3 times, with an estimated
total duration of 10 hours. A total of 87 ml of blood will be drawn. There are
no direct toxic effects associated with the administration of 99mTc-Fucoidan,
except for the risks inherent to radiation exposure. The maximum exposure in
this study is 2.5 mSv. As a phase I, tolerability, biodistribution and
dosimetry study, this trial involves healthy volunteers.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
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
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2017-001015-36-NL |
| ClinicalTrials.gov | NCTisaangevraagd |
| CCMO | NL64194.018.17 |