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NOT YET RECRUITING
NCT07835880
PHASE1/PHASE2

[18F]FIDT-10b PET Imaging in Cardiac Amyloidosis

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

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

DRUG

[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.

DRUG

[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.

DRUG

[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.

DRUG

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.

DRUG

[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.

DRUG

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