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RecruitingNCT07130565Updated Sep 8, 2026

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

An observational study in Amyloid, Cardiac Amyloidosis and Amyloidosis, sponsored by Tianjin Medical University. Recruiting at 3 sites in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Tianjin Medical University · Observational

From the registry’s dates

  • Started Nov 2023; still recruiting 2 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Amyloid
  • Cardiac Amyloidosis
  • Amyloidosis

Keywords

  • PET/CT
  • MRI
  • Pan-Amyloid
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 500 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Tianjin Medical University is the lead sponsor of 46 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

(i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated CA (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled 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.

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

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
7 Days
Patient registry
Yes

Groups and cohorts

  • Single Group Assignment

    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.

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

Interventions

  • Diagnostic test18F-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.

06

What researchers measure

Primary outcomes

  1. 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

  1. Diagnostic efficacy

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

    Time frame: 30 days

07

Study locations

3 of 3 sites recruiting
  • The First Affiliated Hospital of University of Science and Technology of China
    Hefei, Anhui 230000, China
    Recruiting
  • The Affiliated Hospital of Qingdao University
    Qingdao, Shandong 266000, China
    Recruiting
  • Tianjin Medical University General Hospital
    Tianjin, Tianjin Municipality 350005, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07130565
Lead sponsor
Tianjin Medical University
Collaborators
Tianjin Medical University General Hospital
Responsible party
Shaobo Yao, PhD (Prof., Tianjin Medical University) — Principal investigator
First posted
Aug 19, 2025
Start date
Nov 1, 2023
Primary completion
Nov 1, 2028 (estimated)
Completion
Nov 1, 2028 (estimated)
Last update
Sep 8, 2026

Study contacts

Haonan Yu, MD
Contact
dreamadam@126.com
+8613821000597

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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