NCT07835880Not yet recruitingPhase 1/2
[18F]FIDT-10b PET Imaging in Cardiac Amyloidosis
Safety, Biodistribution, Dosimetry and Diagnostic Performance of [18F]FIDT-10b in Healthy Subjects and Patients With Cardiac Amyloidosis
Source: ClinicalTrials.gov · Last updated 23 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 17 Sept 2026
- Start date
- 31 Aug 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Peking Union Medical College Hospital
- Diseases
- Amyloidosis
- NCT number
- NCT07835880
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 48
- From 31 Aug 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- 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)
Other
- For part 1 and 2:
- pregnancy or breastfeeding
- severe claustrophobia
- inability or refusal of consent
- diagnosis of primary or secondary AL-CA
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.