Study of Tolerance, Biodistribution and Dosimetry of Fucoidan Radiolabeled by Technetium-99m (NANO-ATHERO)

Assistance Publique - Hôpitaux de Paris

Status and phase

Unknown

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: 99mTc-Fucoidan SPECT

Study type

Interventional

Funder types

Other

Identifiers

NCT03422055

P130201J

Details and patient eligibility

About

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.

Full description

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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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 :