Cardiac Amyloidosis / 18F-92/AV45/TPZA/FT8, 11CPIB / Amyloid · Observational Study

Pan-Amyloid PET/CT in Various Amyloid-Related Disease

ClinicalTrials.gov · September 8, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned observational study registered to evaluate pan-amyloid PET/CT tracers (18F-92/AV45/TPZA/FT8 and 11C-PIB) for diagnosis in amyloid-related diseases. No results are reported in this registry record. The study is currently recruiting and has not yet generated evidence on diagnostic performance or clinical utility.

What was studied

Observational. Amyloid, Cardiac Amyloidosis, Amyloidosis; age from 18 Years; to 80 Years; accepts healthy volunteers. Intervention: Single Group Assignment. n = 500. 3 sites: China.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a recruiting observational registry study with no reported results; it describes a planned diagnostic imaging evaluation in amyloid disease without outcome data.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measure: Standardized uptake value (SUV) (assessed at 30 days)

DesignObservational

PopulationAmyloid, Cardiac Amyloidosis, Amyloidosis; age from 18 Years; to 80 Years; accepts healthy volunteers

Sample size500

InterventionSingle Group Assignment

Setting3 sites: China

Reported figures

Quoted from the source exactly as published.

Planned enrollment500

Primary outcome measureStandardized uptake value (SUV)

Follow-up period30 days

Caveats

This is a registry record only; no results are reported and enrollment is ongoing.
Study design is observational without a control or comparator arm; diagnostic accuracy and clinical utility are not yet established.
No information provided on inclusion/exclusion criteria, specific amyloid subtypes, or imaging acquisition/analysis protocols.
Primary outcome is a radiological metric (SUV); clinical endpoints and diagnostic performance measures are not stated.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Observational, non-randomized, diagnostic imaging study without control arm.

Directness

moderate

Diagnostic test evaluation in relevant amyloid disease population; clinical utility not yet demonstrated.

Consistency

insufficient

No results reported; cannot assess consistency with other studies.

Risk of bias

insufficient

Study ongoing; methods detail sparse; bias assessment premature.

Sample adequacy

moderate

Estimated 500 participants; adequate for imaging registry, but enrollment not yet complete.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07130565). This is a study registration, not published results. Lead sponsor: Tianjin Medical University. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 500 participants (ESTIMATED). Conditions: Amyloid, Cardiac Amyloidosis, Amyloidosis. Interventions: DIAGNOSTIC_TEST: 18F-92/AV45/TPZA/FT8, 11CPIB. Primary outcome measures: Standardized uptake value (SUV) , 30 days. Brief summary: To evaluate the potential usefulness of 18F-92/AV45/TPZA/FT8, 11C-PIB positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various Pan-Amyloid-related disease patients.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Cardiac Amyloidosis18F-92/AV45/TPZA/FT8, 11CPIBAmyloidTianjin Medical UniversityAmyloidosisNCT07130565