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

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.

Study Overview

• Status: Unknown
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: 99mTc-Fucoidan SPECT

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 75018
      • Groupe Hospitalier Bichat - Claude Bernard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 99mTc-Fucoidan SPECT	Drug: 99mTc-Fucoidan SPECT; Intravenous administration of 99mTc-Fucoidan on healthy volunteers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Biodistribution of 99mTc-Fucoidan after intravenous administration	during 24h after injection
Dosimetry of 99mTc-Fucoidan after intravenous administration	during 24h after injection

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2018
• Primary Completion (ANTICIPATED): May 1, 2018
• Study Completion (ANTICIPATED): July 31, 2018

Study Registration Dates

• First Submitted: January 15, 2018
• First Submitted That Met QC Criteria: February 2, 2018
• First Posted (ACTUAL): February 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2018
• Last Update Submitted That Met QC Criteria: February 2, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: safety 99mTc-Fucoïdane scintigraphy
• Additional Relevant MeSH Terms: Antineoplastic Agents; Gastrointestinal Agents; Anticoagulants; Anti-Ulcer Agents; Fucoidan
• Other Study ID Numbers: P130201J

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No