Pan-Amyloid PET/CT in Various Amyloid-Related Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 18F-92/AV45/TPZA/FT8, 11CPIB.
- Who it may be relevant to
- Registry conditions: Amyloid, Cardiac Amyloidosis, Amyloidosis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Subjects with various Pan-Amyloid-related disease patients underwent 18F-92/AV45TPZA/FT8, 11C-PIB PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-92/AV45TPZA/FT8, 11C-PIB PET/CT were calculated.
Interventions
- Diagnostic test 18F-92/AV45/TPZA/FT8, 11CPIB
Each subject receive a single intravenous injection of 18F-92/AV45/TPZA/FT8, 11C-PIB and undergo PET/CT or MRI imaging within the specificed time.
Primary outcome measures
- Standardized uptake value (SUV) [Time frame: 30 days]
Secondary outcome measures (1)
- Diagnostic efficacy [Time frame: 30 days]
Eligibility criteria
Inclusion criteria
\- (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated cardiac amyloidosis (supporting evidence may include MRI, CT, serum markers and pathology report); (iii) patients who had scheduled Pan-Amyloid PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
Exclusion criteria
\- (i) patients with non-CA lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 2 centers
- The First Affiliated Hospital of University of Science and Technology of China — Hefei
- Tianjin Medical University General Hospital — Tianjin
Identifiers
NCT: NCT07130565 · TJMUGH-11