Exploring the Utility of [18F]3F4AP for Demyelination Imaging in Controls, Neurodegeneration and Traumatic Brian Injury
NCT ID: NCT04710550
Last Updated: 2024-01-30
Study Results
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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ACTIVE_NOT_RECRUITING
PHASE1
8 participants
INTERVENTIONAL
2021-01-25
2025-12-01
Brief Summary
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* Aim 1) Assess the safety of \[18F\]3F4AP in healthy volunteers and subjects with traumatic brain injury (TBI) and neurocognitive impaired subjects (AD/MCI). Hypothesis 1: Administration of \[18F\]3F4AP will result in no changes in vitals or other adverse events.
* Aim 2) Assess the radiation doses to the main organs in healthy volunteers. Hypothesis 2: the radiation doses to each organ will be comparable in all subjects and within the acceptable limits.
* Aim 3) Assess the pharmacokinetics of a bolus infusion of \[18F\]3F4AP in humans including healthy volunteers and patients. Hypothesis 3: the pharmacokinetics of \[18F\]3F4AP at the whole brain level will be similar in controls, TBI and AD/MCI subjects. The kinetics in demyelinated lesions will be slower than in healthy areas.
* Aim 4) Correlate MR images with \[18F\]3F4AP PET images. Hypothesis 4A: all the lesions seen on the MRI will show increased signal (VT or SUV) on the PET images. Hypothesis 4B: some of the lesions on the MRI will show increased signal (VT or SUV) on the PET but not all.
* Aim 5) Correlate \[18F\]3F4AP PET signal with neuropsychological testing in people with TBI and AD/MCI. Hypothesis 5A: increased PET signal (VT or SUV) will correlate with impaired Mini Mental State Examination (MMSE).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Safety/Dosimetry Cohort
F18-3F4AP
PET Scan
Traumatic Brain Injury
F18-3F4AP
PET Scan
AD/MCI
F18-3F4AP
PET Scan
Healthy Controls
F18-3F4AP
PET Scan
Interventions
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F18-3F4AP
PET Scan
Eligibility Criteria
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Inclusion Criteria
18 Years
90 Years
ALL
Yes
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Marc D.Normandin, Ph.D
Associate Professor
Principal Investigators
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Marc Normandin, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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Ramos-Torres K, Sun Y, Takahashi K, Zhou YP, Brugarolas P. Common anesthetic used in preclinical PET imaging inhibits metabolism of the PET tracer [18F]3F4AP. J Neurochem. 2024 Sep;168(9):2577-2586. doi: 10.1111/jnc.16118. Epub 2024 May 1.
Other Identifiers
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2020P002254
Identifier Type: -
Identifier Source: org_study_id
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