Healthy Volunteer Clinical Trial
Official title:
Study of Tolerance, Biodistribution and Dosimetry of Fucoidan Radiolabeled by Technetium-99m
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 allow
for better identification of patients at risk of acute events. We showed that 99mTechnetium
(99mTc)-labeled fucoidan was able to target P-selectine expressed by activated platelets in
vitro in humans and in vivo in a model of abdominal aortic aorta thrombus and endocarditic
vegetations in rats.
One of the objectives of the Nanoathero program is the clinical translation of the
99mTc-fucoidan. As a first step, we will assess the safety, biodistribution and dosimetry of
this new radiopharmaceutical in humans.
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 allow
for better identification of patients at risk of acute events. We showed that
99mTechnetium-labelled fucoidan was able to target P-selectin expressed by activated
platelets in vitro in humans and in vivo in a model of abdominal aortic aorta thrombus and
endocarditic vegetations in rats.
NanoAthero is a monocenter, interventional, open-labeled, first-in-man study to evaluate
tolerance of 99mTc-Fucoïdane in healthy volunteers.
Healthy volunteers registered in the Bichat Centre for Clinical Investigations (CCI) will be
contacted by email to participate in the study. The selection visit will be organized by the
CCI according to the availability of the healthy volunteer.
V0: selection/inclusion visit: pre-audit of eligibility criteria, demographic data, medical
examination, clinical examination and measurement of vital signs, urinary pregnancy test for
women of childbearing potential, blood samples (hematology and biochemistry analyses) and
12-lead ECG.
V1: 99mTc-Fucoidan scintigraphy. The delay between the inclusion visit and the completion of
the scan is 30 ± 7 days. The visit will include verification and confirmation of the consent
of the healthy volunteer, clinical examination and measurement of vital signs, urinary
pregnancy test for women of childbearing age, blood samples (hematology and biochemistry
analyses) and 12-lead ECG.
Whole-body scintigraphic acquisitions will be performed 30 min, 90 min, 3 hours, 6 hours and
24 hours after intravenous administration of 99mTc-Fucoidan for the evaluation of
biodistribution and dosimetry. Vital signs will be monitored 5 min, 15 min, 30 min, 60 min,
90 min, 3 hours, 6 hours and 24 hours after intravenous administration of 99mTc-Fucoidan.
24-hour urine collection will be performed for dosimetry assessment.
V2: End of research visit will be carried out 7 ± 3 days after administration of
99mTc-Fucoidan, and will include medical interview, clinical examination, measurement of
vital signs, blood samples (hematology and biochemistry analyses) and 12-lead ECG.
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