Washington University School of Medicine
St Louis, Missouri, 63110, United States
Location status: Recruiting
Location contact
Jayashree Rajamanickam
CONTACT
Kelley Jackson
CONTACT
NCT Number: NCT06439992
The purpose of this research study is to determine the safety of a radiotracer 18F-Fluselenamyl using positron emission tomography (PET) imaging.
Interested in participating?
Request Info18 year and older
All sexes
Observational
St Louis, Missouri, 63110, United States
Location status: Recruiting
Jayashree Rajamanickam
CONTACT
Kelley Jackson
CONTACT
The investigators will first complete whole-body PET dosimetry studies in healthy adult normal volunteers to calculate the actual radiation dose of each human organ and determine the allowable dose for a human subject when receiving a single dose for a PET scan.
Second, imaging of the brain and neck will be completed in a wide range of ages of healthy adult normal control participants and participants with mild cognitive impairment, both male and females to characterize 18F-Fluselenamyl uptake in the brain, its binding to beta-amyloid plaques, and radiolabeled metabolite will be completed. Amyloid is a protein related to dementia of Alzheimer's disease. 11C-PIB PET imaging and MRI of the brain will also be completed in the same participants and the data will be compared with 18F-Fluselenmayl. 11C-PIB and 18F-Fluselenamyl both bind to beta-amyloid plaques.
Finally, a comparison of the normal control participants to patients with Alzheimer's disease will be completed.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive a single intravenous bolus injection of 10 mCi ± 20% of the investigational radiotracer 18F-Fluselenamyl and will undergo an 18F-Fluselenamyl PET/CT scan of the head and neck.
Other names: 18F-FSA
Time frame: Through study completion, an average of 1 year
Whole-body PET/CT images (skull vertex to proximal thighs) will be obtained in 8 healthy volunteers (4 males and 4 females) for up to a maximum of 4.5 hours immediately following intravenous (IV) injection of 10 mCi ± 20% of [18F]-Fluselenamyl (dosage range calculated from rodent dosimetry data extrapolated to humans).
The primary outcome measure is to quantify each organ's radiation exposure (rad/mCi).
Time frame: Through study completion, an average of 2 years
To assess the sensitivity of [18F]-Fluselenamyl to image Amyloid beta in the setting of mild cognitive impairment, and conduct a comparative analysis of PET imaging data using [11C]-PIB imaging in the same participants.
Contact information is provided by the study sponsor or research team.
Jayashree Rajamanickam
CONTACT
Kelley Jackson
CONTACT
Washington University School of Medicine
Other
Beta Amyloid PET Imaging for Alzheimer Disease: [18F]-Fluselenamyl (Alternative Vehicle) Comparison With [11C]-PIB (FSA-PIB AD)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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