NCT03422055|UnknownPhase 1DMC
Study of Tolerance, Biodistribution and Dosimetry of Fucoidan Radiolabeled by Technetium-99m
NANO-ATHERO
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Sponsor study identifier
interventional
10
1 country
1
Study Start
February 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 31, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 15, 2018
Actual (reported)February 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 5, 2018
Actual (reported)May 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 31, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Adverse events and serious adverse events after 99m Tc-Fucoidan IV administration
Number and percentage of subjects with adverse events and serious adverse events based on clinical, ECG and biological monitoring until 7 days after 99mTc-Fucoidan intravenous administration
up to 7 days
Biodistribution of 99mTc-Fucoidan after intravenous administration
during 24h after injection
Dosimetry of 99mTc-Fucoidan after intravenous administration
during 24h after injection
Intravenous administration of 99mTc-Fucoidan on healthy volunteers.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Groupe Hospitalier Bichat - Claude Bernard
Paris, Île-de-France Region, 75018, France
Oostveen RF, Zheng KH, Kaiser Y, Nurmohamed NS, Kroon J, de Wit TC, Poel E, Aerts J, Rouzet F, Stroes ESG, Letourneur D, Verberne HJ, Chauvierre C, Stahle MR. First-in-human study of 99mTc-labeled fucoidan, a SPECT tracer targeting P-selectin. EJNMMI Res. 2024 Nov 19;14(1):112. doi: 10.1186/s13550-024-01173-8.
Dominique Le Guludec, MD, PhD
Assistance Publique - Hôpitaux de Paris
First Submitted
January 15, 2018
First Posted
February 5, 2018
Study Start
February 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 2018
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 31, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 5, 2018
Record last verified: 2018-01
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