[18F]-F13640 as a New Brain Radiopharmaceutical

Civil Hospices of Lyon

Status and phase

Completed

Early Phase 1

Conditions

Healthy Subjects

Neurological Pathology

Treatments

Drug: [18F]F13640

Study type

Interventional

Funder types

Other

Identifiers

NCT03347331

2017-002722-21 (EudraCT Number)

69HCL16-0770

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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