drugset / Trial / NCT03422055

Study of Tolerance, Biodistribution and Dosimetry of Fucoidan Radiolabeled by Technetium-99m

NCT03422055 ↗

Phase 1 Unknown 10 enrolled Assistance Publique - Hôpitaux de Paris
NaSingle-groupOpen-labelDiagnostic

Summary

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.

Timeline

Start
2018-02
Primary completion
2018-05
Completion
2018-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject 99mTc-Fucoidan Diagnostic / imaging agent 370 mbq Intravenous

Indications

No indication recorded.