ClinicalTrials.gov record NCT07130565

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old to 80 years old
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective observational study enrolls adults with suspected or known amyloid-related disease to undergo a single PET/CT (or MRI) using the tracers 18F-92/AV45/TPZA/FT8 and 11C-PIB. Each participant receives one intravenous injection and imaging; tracer uptake is measured as standardized uptake value (SUV). The study will calculate diagnostic performance measures (sensitivity, specificity, PPV, NPV, accuracy).

What it is studying. The study tests whether PET/CT scans using 18F-92/AV45/TPZA/FT8 and 11C-PIB identify primary and metastatic amyloid-related lesions and how much tracer they take up. It measures SUV in target lesions and evaluates diagnostic performance (sensitivity, specificity, positive and negative predictive values, and accuracy).

What the researchers hope to learn. To quantify tracer uptake (SUV) in amyloid-related lesions and to determine diagnostic performance metrics (sensitivity, specificity, PPV, NPV, accuracy) for Pan-Amyloid PET/CT.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Diagnostic test
  • 18F-92/AV45/TPZA/FT8, 11CPIB

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants receive a single intravenous injection of the tracer(s) listed in the record (18F-92/AV45/TPZA/FT8, 11C-PIB) and undergo PET/CT or MRI imaging within the specified time. Imaging may be done for initial assessment or to check for recurrence; scans will be analyzed to measure tracer uptake in lesions. You must be able to give written informed consent; pregnant people are not eligible.

How the study is structured. A prospective observational cohort study. Participants receive a single intravenous injection of the listed PET tracers and have PET/CT or MRI imaging within the specified window. Images are analyzed for tracer uptake (SUV) and compared to diagnostic reference data. No treatment is assigned by the study; target study duration is 7 days per participant.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on wild-type ATTR amyloidosis

This trial is also listed on this site under ATTRv amyloidosis.

Clinical trials121 trials listed for wild-type ATTR amyloidosisEvery trial the registry lists for wild-type ATTR amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in wild-type ATTR amyloidosis researchLatest monthly update: September 2026. Includes: Frailty and support needs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Nov 1, 2023
Primary completion
Nov 1, 2028 (estimated)
Study completion
Nov 1, 2028 (estimated)
Target enrollment
500 participants (estimated)
Last updated on registry
Sep 8, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Tianjin Medical University
Principal investigator
Shaobo Yao, PhD, Prof.
Tianjin Medical University
Collaborators
  • Tianjin Medical University General Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (3)

  • The First Affiliated Hospital of University of Science and Technology of ChinaRecruiting

    Hefei, Anhui, 230000 · China

  • The Affiliated Hospital of Qingdao UniversityRecruiting

    Qingdao, Shandong, 266000 · China

  • Tianjin Medical University General HospitalRecruiting

    Tianjin, Tianjin Municipality, 350005 · China

Terms used on this page · explanations by MedicalUpdates.ai

positron emission tomography
A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
computed tomography
An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
legal representative
A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
assent
A child's or dependent adult's agreement to take part, given alongside the formal consent of a parent or legal representative.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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