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

T

Tianjin Medical University

Status

Enrolling

Conditions

Amyloid
Cardiac Amyloidosis
Amyloidosis

Treatments

Diagnostic Test: 18F-92/AV45/TPZA/FT8, 11CPIB

Study type

Observational

Funder types

Other

Identifiers

NCT07130565
TJMUGH-11

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

500 participants in 1 patient group

Single Group Assignment
Description:
Each subject receive a single intravenous injection of 18F-92/AV45/TPZA/FT8, 11CPIB and undergo PET/CT or MRI imaging within the specificed time.
Treatment:
Diagnostic Test: 18F-92/AV45/TPZA/FT8, 11CPIB

Trial contacts and locations

2

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Central trial contact

Haonan Yu, MD

Data sourced from clinicaltrials.gov

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