A new heart scan agent for detecting cardiac amyloidosis
Tests a new scan agent for finding cardiac amyloidosis in adults.
Plain-language title generated from the registry record
Registry title: [18F]FIDT-10b PET Imaging in Cardiac Amyloidosis
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 1/2
Where in China
- Peking Union Medical College HospitalBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Peking Union Medical College Hospital
- Trial code
- NCT07835880
- Record updated
- 23 September 2026
- Original description
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).Read full original descriptionShow less
Safety, Biodistribution, Dosimetry and Diagnostic Performance of [18F]FIDT-10b in Healthy Subjects and Patients With Cardiac Amyloidosis
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).
Inclusion: 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: 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; 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); 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:; contraindications for MRI (eGFR<30ml/min/1.73m2; gadolinium allergy; metallic implants or device not suited for MRI); For part 1 and 2:; pregnancy or breastfeeding; severe claustrophobia; inability or refusal of consent; diagnosis of primary or secondary AL-CA.