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

• Status: Unknown status
• Trial end date: 2018-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Fucoidan

Criteria

Inclusion criteria :

• Adult volunteer

• No chronic progressive disease

• Absence of long term medication

• BMI between 18 and 35

• Absence of chronic infection by HIV, HVB, HCV

• Absence of significant biological abnormality in the screening report

• Affiliation to a social security system or CMU

• Signed informed consent

• Females with childbearing potential as well as males should use effective contraceptive methods

Exclusion criteria :

• Pregnant or nursing woman

• Person of exclusion period of research protocol

• Person in detention by judicial or administrative decision

• Protected person (maintenance of justice, tutelage, legal guardianship)

• Person unable to express consent