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

Healthy Volunteer Clinical Trial

— NANO-ATHERO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03422055
• Other study ID #: P130201J
• Status: Not yet recruiting
• Phase: Phase 1
• First received: January 15, 2018
• Last updated: February 2, 2018
• Start date: February 2018
• Est. completion date: July 31, 2018

Study information

• Verified date: January 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Dominique Le Guludec, MD, PhD
• Phone: 01.40.25.84.13
• Email: dominique.leguludec[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: July 31, 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• 99mTc-Fucoidan SPECT
Intravenous administration of 99mTc-Fucoidan on healthy volunteers.

Locations

Country	Name	City	State
France	Groupe Hospitalier Bichat - Claude Bernard	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Biodistribution of 99mTc-Fucoidan after intravenous administration		during 24h after injection
Secondary	Dosimetry of 99mTc-Fucoidan after intravenous administration		during 24h after injection