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

NCT ID: NCT03422055

Last Updated: 2018-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-28
• Study Completion Date: 2018-07-31

Brief 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.

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.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

99mTc-Fucoidan SPECT

Group Type: EXPERIMENTAL

99mTc-Fucoidan SPECT

Intervention Type: DRUG

Intravenous administration of 99mTc-Fucoidan on healthy volunteers.

Interventions

99mTc-Fucoidan SPECT

Intravenous administration of 99mTc-Fucoidan on healthy volunteers.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dominique Le Guludec, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Groupe Hospitalier Bichat - Claude Bernard

Paris, Île-de-France Region, France

Countries

France

Central Contacts

Dominique Le Guludec, MD, PhD

Role: CONTACT

dominique.leguludec@aphp.fr

01.40.25.84.13 ext. +33

François Rouzet, MD, PhD

Role: CONTACT

francois.rouzet@aphp.fr

01.40.25.64.11 ext. +33

References

Oostveen RF, Zheng KH, Kaiser Y, Nurmohamed NS, Kroon J, de Wit TC, Poel E, Aerts J, Rouzet F, Stroes ESG, Letourneur D, Verberne HJ, Chauvierre C, Stahle MR. First-in-human study of 99mTc-labeled fucoidan, a SPECT tracer targeting P-selectin. EJNMMI Res. 2024 Nov 19;14(1):112. doi: 10.1186/s13550-024-01173-8.

Reference Type: DERIVED

PMID: 39562382 (View on PubMed)

Other Identifiers

P130201J

Identifier Type: -

Identifier Source: org_study_id