[18F]-F13640 as a New Brain Radiopharmaceutical

Early Phase 1

Completed

• Conditions: Neurological Pathology; Healthy Subjects
• Interventions: Drug: [18F]F13640

• Registration Number: NCT03347331
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-03
• Study First Submitted QC: 2017-11-17
• Study First Posted: 2017-11-20
• Study Start: 2018-04-23
• Primary Completion: 2021-04-23
• Study Completion: 2021-12-02
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-28
• Last Update Posted: 2022-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Input function group	[18F]F13640	Each subject underwent a 90 min acquisition PET scan with concomitant arterial blood sampling
Test-retest group	[18F]F13640	Each subject underwent 2 PET scans distant from 1 to 3 weeks

Primary Outcome Measures

Name	Time	Method
Binding potentials	180 minutes	Binding potentials are calculated using compartimental modelling techniques.

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Bron, France