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

Tianjin Medical University500 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Amyloid Cardiac Amyloidosis Amyloidosis

Interventions

18F-92/AV45/TPZA/FT8, 11CPIBDIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Standardized uptake value (SUV)

Standardized uptake value (SUV) of 18F-92/AV45/TPZA/FT8, 11C-PIB for each target lesion of subject or suspected Pan-Amyloid related diseases.

Time frame: 30 days

Secondary Outcomes

Diagnostic efficacy

The sensitivity, specificity and accuracy of Pan-Amyloid PET/CT were calculated.

Time frame: 30 days

Central Contacts

Haonan Yu, MD

CONTACT

+8613821000597 dreamadam@126.com

Data from ClinicalTrials.gov

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