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CompletedNCT03347331F13640Updated Sep 12, 2025

[18F]-F13640 as a New Brain Radiopharmaceutical

An Early Phase 1 interventional study of [18F]F13640 and [18F]F13640 in Neurological Pathology and Healthy Subjects, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-12.

Sponsored by Hospices Civils de Lyon · Early Phase 1, Interventional, and Basic science

Phase
Early Phase 1
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
20 Years to 45 Years
Sex
Male
01

Study summary

This clinical assay is designed to validate that [18F]F13640 as a radiotracer of 5-HT1A functional receptors. A first group of healthy subjects underwent a PET scan with arterial blood sampling to determine the kinetic model of the tracer. A second group of healthy subjects underwent a classical test-retest study (i.e two distant PET scans) to determine the reproducibility of measures.

02

Conditions studied

  • Neurological Pathology
  • Healthy Subjects

Keywords

  • PET imaging- Serotonin-Radiotracer
03

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy Subjects
  • Weight between 50 kg and 90 kg
  • Affiliated to a social security or similar scheme
  • Not subject to any legal protection measures

Exclusion criteria

Exclusion Criteria:

Subjects with neurologic or psychiatric disease including all substance addictions

  • Daily smokers
  • Active infectious disease
  • MRI contraindications
  • PET contraindications determined with FDG injection
  • Subjects deprived of their liberty by judicial or administrative decision
  • Subjects unable to sign written consent for participation in the study.
  • Severe and progressive medical pathology
  • Volunteer who has exceeded the annual amount of compensation authorized for participation in research protocols
04

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Input function group

    Each subject underwent a 90 min acquisition PET scan with concomitant arterial blood sampling

    Drug: [18F]F13640

  • Experimental
    Test-retest group

    Each subject underwent 2 PET scans distant from 1 to 3 weeks

    Drug: [18F]F13640

Interventions

  • Drug[18F]F13640

    Radiotracer injection and PET scan acquisition of 90 min: \*150 Mbq + 1 MBq/Kg of \[18F\]F13640 at t=0 min Arterial Blood Sampling during the 90min acquisition

  • Drug[18F]F13640

    2 Radiotracer injections and PET scan acquisition of 90 min distant from 1 to 3 weeks: For each exam: 150 MBq + 1 MBq/kg of \[18F\]F13640 at t=0 min

05

What researchers measure

Primary outcomes

  1. Binding potentials

    Binding potentials are calculated using compartimental modelling techniques.

    Time frame: 180 minutes

06

Study locations

1 site
  • Hospices Civils de Lyon
    Bron, France
07

References and documents

Publications

  • Colom M, Costes N, Redoute J, Dailler F, Gobert F, Le Bars D, Billard T, Newman-Tancredi A, Zimmer L. 18F-F13640 PET imaging of functional receptors in humans. Eur J Nucl Med Mol Imaging. 2020 Jan;47(1):220-221. doi: 10.1007/s00259-019-04473-7. Epub 2019 Aug 14. No abstract available. PubMed 31414208 ↗
08

Registry details

Key details

Study ID
NCT03347331
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Nov 20, 2017
Start date
Apr 23, 2018
Primary completion
Apr 23, 2021
Completion
Dec 2, 2021
Last update
Sep 12, 2025

Study contacts

Scheiber Christian
study chair · Hospices Civils de Lyon

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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