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Radiation Dosimetry of the 18 kDa Translocator Protein Ligand [18F]PBR111 in Humans

NCT06398392 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-09-16

No results posted yet for this study

Summary

The 18 kDa translocator protein (TSPO) is a mitochondrial protein that becomes overexpressed during neuroinflammatory conditions, such as in Alzheimer's disease or multiple sclerosis. TSPO is of interest because it serves as a marker for microglial and astrocytic activity, measurable via in vivo positron emission tomography (PET) molecular imaging. \[18F\]PBR111 is a second-generation TSPO PET radioligand with high signal specificity but a sensitivity to TSPO polymorphism, in comparison with first-generation ligands. This study focused on the biodistribution and dosimetry of \[18F\]PBR111 in healthy humans.

Conditions

  • Dosimetry
  • Healthy

Interventions

DRUG

[18F]PBR111

\[18F\]PBR111 is a radiotracer produced at University Hospital of Geneva in a radiopharmaceutical GMP facility. The drug product is provided as sterile solution for intravenous injection in a glass vial containing 10 mL (max) of formulated product, the maximal applicable dose being 200 MBq.

PROCEDURE

PBR111 injection

\[18F\]PBR111 will be administered once, intravenously in the antecubital fossa at a dose of 200 MBq

DEVICE

PET scan

Upon administration of the radiotracer, a 120-minute PET/CT scan will be initiated.

RADIATION

PBR111 dosimetry

to establish the exposure of the organs/tissues to a standard radioactive dose (200 MBq) of \[18F\]PBR111

Sponsors & Collaborators

  • Prof. Daniele Zullino

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-24
Primary Completion
2024-07-30
Completion
2024-07-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06398392 on ClinicalTrials.gov