Healthy VolunteerPhase 1NANO-ATHERONCT03422055
Study of Tolerance, Biodistribution and Dosimetry of Fucoidan Radiolabeled by Technetium-99m
A Phase 1 study testing 99mTc-Fucoidan SPECT in people with Healthy Volunteer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- 99mTc-Fucoidan SPECT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2018to 31 Jul 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Affiliation to a social security system or CMU
- Signed informed consent
- Females with childbearing potential as well as males should use effective contraceptive methods
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Bichat - Claude Bernard
Paris, Île-de-France Region, 75018
About this study
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.
Read the 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
- Being tested
- 99mTc-Fucoidan SPECT
- Keywords
- safety 99mTc-Fucoïdane scintigraphy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mTc-Fucoidan SPECTDrug
Intravenous administration of 99mTc-Fucoidan on healthy volunteers.
| Study group | Role | What they receive |
|---|---|---|
| 99mTc-Fucoidan SPECT | Experimental | Not described Receives: Drug: 99mTc-Fucoidan SPECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 7 days
Secondary outcomes (2)
Biodistribution of 99mTc-Fucoidan after intravenous administration
Measured: during 24h after injection
Dosimetry of 99mTc-Fucoidan after intravenous administration
Measured: during 24h after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study startFeb 2018 (estimated)
- Primary completionMay 2018 (estimated)
- Study completion31 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique Le Guludec, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422055
- Sponsor's protocol ID
- P130201J
- Acronym
- NANO-ATHERO
- Status last verified
- Jan 2018
- First submitted
- 15 Jan 2018
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39562382
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Tolerance, Biodistribution and Dosimetry of Fucoidan Radiolabeled by Technetium-99m
- ClinicalTrials.gov ID
- NCT03422055
- Acronym / sponsor ID
- NANO-ATHERO / P130201J
- Conditions
- Healthy Volunteer
- Keywords
- safety 99mTc-Fucoïdane scintigraphy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2018 (estimated)
- Primary completion
- May 2018 (estimated)
- Study completion
- 31 Jul 2018 (estimated)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 99mTc-Fucoidan SPECT | Experimental | Drug: 99mTc-Fucoidan SPECT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult volunteer
- No chronic progressive disease
- Absence of long term medication
- BMI between 18 and 35
- Absence of chronic infection by HIV, HVB, HCV
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 99mTc-Fucoidan SPECTIntravenous administration of 99mTc-Fucoidan on healthy volunteers. | Drug | 99mTc-Fucoidan SPECT |
Primary outcome
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
2 secondary outcomes
Biodistribution of 99mTc-Fucoidan after intravenous administration
Time frame: during 24h after injection
Dosimetry of 99mTc-Fucoidan after intravenous administration
Time frame: during 24h after injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Derived from this study: PubMed 39562382Oostveen 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.
- Individual participant dataSharing planned: Undecided
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Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique Le Guludec, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 99mTc-Fucoidan SPECT in people with Healthy Volunteer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominique Le Guludec, MD, PhD (01.40.25.84.13 ext. +33, dominique.leguludec@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events and serious adverse events after 99m Tc-Fucoidan IV administration (time frame: up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03422055, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.