[18F]-F13640 as a New Brain Radiopharmaceutical

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-23

Study Completion Date

2021-12-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Neurological Pathology Healthy Subjects

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Input function group

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

Group Type EXPERIMENTAL

[18F]F13640

Intervention Type DRUG

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

Test-retest group

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

Group Type EXPERIMENTAL

[18F]F13640

Intervention Type DRUG

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

Interventions

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[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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes