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[18F]FIDT-10b PET Imaging in Cardiac Amyloidosis
Sponsor: Peking Union Medical College Hospital
Summary
This is a first in human study that will assess the safety, pharmacokinetics, biodistribution and diagnostic performance of \[18F\]FIDT-10b (fluorine-18 labeled FIDT-10b), a positron emission tomography (PET) agent. This agent has the potential to specifically identify the involved myocardium of patients with transthyretin cardiac amyloidosis (ATTR-CA).
Official title: Safety, Biodistribution, Dosimetry and Diagnostic Performance of [18F]FIDT-10b in Healthy Subjects and Patients With Cardiac Amyloidosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2026-08-31
Completion Date
2028-12-31
Last Updated
2026-09-23
Healthy Volunteers
Yes
Interventions
[18F]FIDT-10b
An I.V. bolus injection of up to 10 millicurie (mCi) \[18F\]FIDT-10b will be administered, followed by a PET/CT scan.
[18F]FIDT-10b
An I.V. bolus injection of up to 10 millicurie (mCi) \[18F\]FIDT-10b will be administered, followed by a PET/CT or PET/MRI scan.
[18F]FIDT-10b
An I.V. bolus injection of up to 10 millicurie (mCi) \[18F\]FIDT-10b will be administered, followed by a PET/CT scan.
99mTc-PYP
An I.V. bolus injection of up to 30 millicurie (mCi) 99mTc-PYP will be administered, followed by a SPECT planar and SPECT/CT scan.
[18F]FIDT-10b
An I.V. bolus injection of up to 10 millicurie (mCi) \[18F\]FIDT-10b will be administered, followed by a PET/CT or PET/MRI scan.
99mTc-PYP
An I.V. bolus injection of up to 30 millicurie (mCi) 99mTc-PYP will be administered, followed by a SPECT planar and SPECT/CT scan.
Locations (1)
Peking Union Medical College Hospital
Beijing, China