A Phase 1/2 interventional study of [18F]FIDT-10b and [18F]FIDT-10b in Transthyretin Cardiac Amyloidosis and Light Chain Cardiac Amyloidosis, sponsored by Peking Union Medical College Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Peking Union Medical College Hospital · Phase 1/2, Interventional, and Diagnostic
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).
Light chain cardiac amyloidosis (AL-CA) and transthyretin cardiac amyloidosis (ATTR-CA) are the two leading causes of cardiac amyloidosis with tremendous impact on patients. Regardless of the underlying cause, the clinical course of cardiac amyloidosis ultimately culminates in impaired cardiac function resulting from amyloid deposition, manifesting as infiltrative cardiomyopathy, conduction abnormalities, and cardiac sympathetic and parasympathetic denervation. These cardiac functional impairments are irreversible. Therefore, early etiological diagnosis and effective therapeutic intervention prior to the progress of severe cardiac dysfunction are importance.
There is an urgent need for non-invasive, sensitive, accurate, and visualizable approaches for the diagnosis and subtyping of cardiac amyloidosis. Current guidelines recommend bone scintigraphy for the non-invasive diagnosis of ATTR-CA, with a diagnostic specificity exceeding 90% but a sensitivity of only approximately 71%, raising the possibility of missed diagnosis or delayed diagnosis in a subset of patients. This has further propelled the development of PET molecular probes that specifically target amyloid proteins.
The investigators have preclinical data demonstrating that [18F]FIDT-10b selectively binds to ATTR deposits with high affinity in vitro via a combination of intermolecular forces, including van fer Waals forces, hydrophobic- hydrophobic interactions, π-π stacking, and hydrogen bonds, with the β-sheet architecture, supporting its potential utility for specific imaging of affected myocardium in patients with ATTR-CA. The investigators propose that this agent has significant potential for clinical translation. This first-in-human study is designed to evaluate the safety, pharmacokinetics, biodistribution in patients with cardiac amyloidosis and healthy participants (Part 1), and diagnostic performance of [18F]FIDT-10b in individuals with suspected or confirmed ATTR-CA (Part 2). This study will provide critical insights into the performance of [18F]FIDT-10b PET imaging as a potential non-invasive imaging tool for the detection of ATTR-CA and compared with routine clinical 99mTc-PYP SPECT imaging.
290 studies on the registry are indexed under Amyloidosis; 92 are open to participants now.
This study's planned enrollment of 48 is close to the median of 46 across 189 interventional studies indexed under Amyloidosis.
Browse Amyloidosis studies →Peking Union Medical College Hospital is the lead sponsor of 1,155 studies on the registry; 475 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For part 1 and 2:
must have given written (signed and dated) and any authorizations required by local law and be able to comply with all study requirements
Only for part 1:
For ATTR-CA participants:
For AL-CA participants:
For healthy participants:
Only for part 2:
Exclusion Criteria:
For part 1 and 2:
Only for part 1:
For ATTR-CA participants:
For AL-CA participants:
co-diagnosis of multiple myeloma, Waldenström macroglobulinemia, or other lymphoproliferative disorders
For healthy participants:
any cardiac-related diseases based on medical history and corresponding clinical evaluations, including electrocardiography, echocardiography, and laboratory tests
Only for part 2:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy participants receive \[18F\]FIDT-10b for PET imaging.
Drug: [18F]FIDT-10b
ATTR-CA participants receive \[18F\]FIDT-10b for PET imaging to see how the drugs work in the myocardium.
Drug: [18F]FIDT-10b · Drug: 99mTc-PYP
AL-CA participants receive \[18F\]FIDT-10b for PET imaging to see how the drugs work in the myocardium.
Drug: [18F]FIDT-10b
Suspected or confirmed ATTR-CA participants receive \[18F\]FIDT-10b for PET imaging to explore the potential diagnostic performance and additional value of 99mTc-PYP scintigraphy.
Drug: [18F]FIDT-10b · Drug: 99mTc-PYP
An I.V. bolus injection of up to 10 millicurie (mCi) \[18F\]FIDT-10b will be administered, followed by a PET/CT scan.
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.
An I.V. bolus injection of up to 10 millicurie (mCi) \[18F\]FIDT-10b will be administered, followed by a PET/CT scan.
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.
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.
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.
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: Through study completion, an average of 3 months
Radiation Dosimetry of [18F]FIDT-10b
OLINDA/EXM will be used to determine the absorbed dose and effective dose per individuals.
Time frame: Through study completion, an average of 3 months
Biodistribution of [18F]FIDT-10b
At different time points after drug injection, perform PET/CT whole-body scans to obtain radioactivity counts in major irradiated organs at each phase, reflecting the drug's biodistribution in the body.
Time frame: Through study completion, an average of 3 months
Identify the ideal time point for imaging after [18F]FIDT-10b injection
Left ventricular myocardial lesion to-blood pool background ratios as a function of time will be measured. The time point resulting in optimal lesion-to-background ratios, taking into account a realistic implementation in clinical practice, will be defined as the ideal time point for imaging.
Time frame: Through study completion, an average of 3 months
Diagnostic performance of [18F]FIDT-10b for ATTR-CA
Assessment of the sensitivity and specificity of PET imaging with \[18F\]FIDT-10b for the diagnosis of ATTR-CA based on visual and semi-quantitative scan interpretation.
Time frame: Through study completion, an average of 3 months
Preliminary assessment of lesion targeting by [18F]FIDT-10b as compared to 99mTc-PYP
Detection rate of visual interpretation will be performed to compare the number of detected lesions using both tracers.
Time frame: Through study completion, an average of 3 months
Plan to share: Yes — Available upon request
Supporting information: Study protocol
Time frame: Within 2 years after the publication of the main results
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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