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Study of tolerability, biodistribution and dosimetry of Technetium-99m radiolabelled Fucoidan


- candidate number28270
- NTR NumberNTR6873
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-nov-2017
- Secondary IDs2017_321 METC AMC Amsterdam
- Public TitleStudy of tolerability, biodistribution and dosimetry of Technetium-99m radiolabelled Fucoidan
- Scientific TitleStudy of tolerability, biodistribution and dosimetry of Technetium-99m radiolabelled Fucoidan
- ACRONYMNANOATHERO
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedThrombosis, Atherosclerosis , Fucoidan
- Inclusion criteriaIn 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 criteriaA 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
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2018
- planned closingdate1-jan-2019
- Target number of participants10
- Interventions99mTc-Fucoidan SPECT/CT
- Primary outcomeTolerability 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)
- TimepointsAfter injection of 99mTc-Fucoidan, t=30min, 1.5h, 3h, 6h, 24h and 7d
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD K.H. Zheng
- CONTACT for SCIENTIFIC QUERIESMD K.H. Zheng
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
EU FP 7
- Publications
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD28-nov-2017 - 16-dec-2017


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