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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03422055
Recruitment Status : Unknown
Verified January 2018 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Not yet recruiting
First Posted : February 5, 2018
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: 99mTc-Fucoidan SPECT Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study of Tolerance, Biodistribution and Dosimetry of Fucoidan Radiolabeled by Technetium-99m
Estimated Study Start Date : February 2018
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : July 31, 2018

Arm Intervention/treatment
Experimental: 99mTc-Fucoidan SPECT Drug: 99mTc-Fucoidan SPECT
Intravenous administration of 99mTc-Fucoidan on healthy volunteers.




Primary Outcome Measures :
  1. Adverse events and serious adverse events after 99m Tc-Fucoidan IV administration [ Time Frame: up to 7 days ]
    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


Secondary Outcome Measures :
  1. Biodistribution of 99mTc-Fucoidan after intravenous administration [ Time Frame: during 24h after injection ]
  2. Dosimetry of 99mTc-Fucoidan after intravenous administration [ Time Frame: during 24h after injection ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03422055


Contacts
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Contact: Dominique Le Guludec, MD, PhD 01.40.25.84.13 ext +33 dominique.leguludec@aphp.fr
Contact: François Rouzet, MD, PhD 01.40.25.64.11 ext +33 francois.rouzet@aphp.fr

Locations
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France
Groupe Hospitalier Bichat - Claude Bernard
Paris, Ile De France, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Dominique Le Guludec, MD, PhD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03422055    
Other Study ID Numbers: P130201J
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
safety 99mTc-Fucoïdane scintigraphy
Additional relevant MeSH terms:
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Fucoidan
Anti-Ulcer Agents
Gastrointestinal Agents
Anticoagulants
Antineoplastic Agents