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

ConditionsTransthyretin Cardiac Amyloidosis Light Chain Cardiac Amyloidosis

Trial statusNot yet recruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorPeking Union Medical College Hospital

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

males or females: age 18-90 years

with a confirmed diagnosis of ATTR-CA by standard criteria

males or females: age 18-80 years

with a confirmed diagnosis of AL-CA by standard criteria

Disqualifiers

pregnancy or breastfeeding

severe claustrophobia

inability or refusal of consent

any condition deemed by the investigator to interfere with study results or increase participant risk

Trial design

Design model

Parallel

Treatments tested in this trial

[18F]FIDT-10b
Drug
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
Drug
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
Drug
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
Drug
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
Drug
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
Drug
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.

Treatment groups

48 Participants

are divided into 4 treatment groups

Group A: Part 1-Dosimetry and Proof of Concept Study-Cohort AExperimental treatment 1 intervention

Group B: Part 1-Dosimetry and Proof of Concept Study-Cohort BExperimental treatment 2 interventions

Group C: Part 1-Dosimetry and Proof of Concept Study-Cohort CExperimental treatment 1 intervention

Group D: Part 2-Diagnostic Performance StudyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Safety and tolerability evaluation (Part 1)

The safety will be assessed by the number and percentage of patients with adverse events; Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.

Time frame

Within 30 days following PET imaging

Focal or diffuse myocardial lesions of ATTR-CA identified with [18F]FIDT-10b PET imaging (Part 2)

The reference standard comprised biopsy-proven extracardiac amyloidosis or pathogenic TTR mutation on genetic testing, in both cases accompanied by typical cardiac imaging appearance; a positive endomyocardial biopsy also served as an independent reference standard.

Time frame