[18F]-F13640 as a New Brain Radiopharmaceutical
F13640
First-in-man Study of [18F]-F13640, a PET Radiopharmaceutical for Functional 5-HT1A Receptor Imaging
2 other identifiers
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Apr 2018
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2017
CompletedFirst Posted
Study publicly available on registry
November 20, 2017
CompletedStudy Start
First participant enrolled
April 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 2, 2021
CompletedSeptember 12, 2025
April 1, 2022
3 years
November 3, 2017
September 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Binding potentials
Binding potentials are calculated using compartimental modelling techniques.
180 minutes
Study Arms (2)
Input function group
EXPERIMENTALEach subject underwent a 90 min acquisition PET scan with concomitant arterial blood sampling
Test-retest group
EXPERIMENTALEach subject underwent 2 PET scans distant from 1 to 3 weeks
Interventions
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
Eligibility Criteria
You may qualify if:
- Healthy Subjects
- Weight between 50 kg and 90 kg
- Affiliated to a social security or similar scheme
- Not subject to any legal protection measures
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospices Civils de Lyon
Bron, France
Related Publications (1)
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.
PMID: 31414208RESULT
Study Officials
- STUDY CHAIR
Scheiber Christian
Hospices Civils de Lyon
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2017
First Posted
November 20, 2017
Study Start
April 23, 2018
Primary Completion
April 23, 2021
Study Completion
December 2, 2021
Last Updated
September 12, 2025
Record last verified: 2022-04