ClinicalTrials.gov record NCT07835880

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 28, 2026

Safety, Biodistribution, Dosimetry and Diagnostic Performance of [18F]FIDT-10b in Healthy Subjects and Patients With Cardiac Amyloidosis

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1/2A study that combines safety and dose-finding (phase 1) with a first look at whether the treatment has an effect (phase 2).
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old and older
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This first-in-human interventional study evaluates [18F]FIDT-10b, a PET imaging agent, in healthy volunteers and people with transthyretin or light-chain cardiac amyloidosis. Part 1 studies safety, biodistribution and radiation dosimetry in healthy participants and people with cardiac amyloidosis. Part 2 evaluates the diagnostic performance of [18F]FIDT-10b in suspected or confirmed ATTR-CA and compares images with routine 99mTc-PYP scintigraphy.

What it is studying. The study is testing whether [18F]FIDT-10b is safe to use in humans, how it distributes in the body and the radiation dose it delivers, and how well PET imaging with this tracer detects and visualizes myocardial amyloid, especially compared with 99mTc-PYP imaging for ATTR-CA.

What the researchers hope to learn. Scientific goals are to assess safety and tolerability, measure biodistribution and radiation dosimetry, identify the best imaging time after tracer injection, and evaluate the diagnostic sensitivity and specificity of [18F]FIDT-10b PET for ATTR-CA, including preliminary comparison with 99mTc-PYP.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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).

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • [18F]FIDT-10b
  • 99mTc-PYP

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • For part 1 and 2:
  • must have given written informed consent (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:
  • males or females: age 18-90 years
  • with a confirmed diagnosis of ATTR-CA by standard criteria
  • For AL-CA participants:
  • males or females: age 18-80 years
  • with a confirmed diagnosis of AL-CA by standard criteria
  • For healthy participants:
  • males or females: age 18-80 years
  • no cardiac-related diseases
  • Only for part 2:
  • males or females: age 18-90 years
  • suspected or confirmed ATTR-CA

Exclusion criteria

  • For part 1 and 2:
  • 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
  • Only for part 1:
  • For ATTR-CA participants:
  • non-ischemic cardiomyopathy due to other causes of myocardial hypertrophy
  • diagnosis of primary or secondary AL-CA
  • contraindications for MRI (eGFR<30ml/min/1.73m2; gadolinium allergy; metallic implants or device not suited for MRI)
  • 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:
  • non-ischemic cardiomyopathy due to other causes of myocardial hypertrophy
  • contraindications for MRI (eGFR<30ml/min/1.73m2; gadolinium allergy; metallic implants or device not suited for MRI)

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will receive an intravenous (IV) bolus injection of the PET imaging agent [18F]FIDT-10b (up to 10 mCi) followed by PET imaging (PET/CT or PET/MRI as described for the study group). Some participants will also receive an IV bolus of 99mTc-PYP (up to 30 mCi) followed by SPECT planar and SPECT/CT imaging. Imaging may be done at multiple time points after injection to assess where the tracer goes in the body (biodistribution) and to measure radiation dosimetry. Study staff will record any side effects and collect safety information for up to about 30 days after imaging; which scans and tracers you receive depends on the study part and cohort.

How the study is structured. Interventional (Phase 1/2), non-randomized, parallel-group study with no masking. The trial has two parts: Part 1 (dosimetry and proof-of-concept) enrolls healthy volunteers and people with ATTR-CA or AL-CA to measure safety, biodistribution and radiation dose after an IV injection of [18F]FIDT-10b followed by PET/CT or PET/MRI scans; some participants also have 99mTc-PYP SPECT imaging. Part 2 (diagnostic performance) enrolls people with suspected or confirmed ATTR-CA to undergo [18F]FIDT-10b PET imaging and 99mTc-PYP scintigraphy to assess diagnostic performance.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on wild-type ATTR amyloidosis

Clinical trials121 trials listed for wild-type ATTR amyloidosisEvery trial the registry lists for wild-type ATTR amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in wild-type ATTR amyloidosis researchLatest monthly update: September 2026. Includes: Frailty and support needs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Aug 31, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Study completion
Dec 31, 2028 (estimated)
Target enrollment
48 participants (estimated)
Last updated on registry
Sep 23, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Peking Union Medical College Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

first in human
The first study in which a treatment is given to people. Safety is the main question and the number of participants is usually small.
pharmacokinetics
How the body absorbs, distributes, breaks down and removes a drug. It is studied by measuring drug levels or related substances at set times after a dose.
positron emission tomography
A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
contraindications
A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
eGFR
A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
echocardiography
An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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