Who may be eligible for the [18F]FT8 PET Imaging in Immunoglobulin Light Chain Amyloidosis trial?

1. Subject Recruitment Participants will be recruited from outpatients and/or inpatient populations of the Hematology Department at Tianjin Medical University General Hospital. The principal investigator and collaborating hematologists will ensure consistent application of diagnosis and enrollment criteria based on standardized guidelines. The planned enrollment includes 20 patients with systemic amyloidosis (including cardiac involvement) and 5 healthy volunteers. 2. Amyloidosis Patients: 2.1 Inclusion Criteria: Subjects must meet all of the following criteria: 1. Adult patients (age ≥ 18 years); 2. Suspected, newly diagnosed, or previously diagnosed with cardiac amyloidosis, with supporting evidence from one or more of the following: cardiac MRI, contrast-enhanced CT, serum biomarkers (e.g., NT-proBNP, Troponin), or histopathological confirmation of amyloidosis. 3. Scheduled to undergo a clinical Pan-Amyloid PET/CT scan as part of standard care or clinical evaluation. 4. Able to understand the study procedures and provide written informed consent. 2.2 Exclusion Criteria Subjects will be excluded based on any of the following: 1. Confirmed non-cardiac amyloidosis or other non-amyloid cardiac pathologies that could confound image interpretation. 2. Pregnancy or breastfeeding. 3. Any medical, psychological, or social condition that, in the opinion of the investigator, would compromise the subject's ability to participate fully or complete the study follow-up. 3\. Healthy Volunteers: 3.1 Inclusion Criteria: Subjects must meet all of the following criteria: 1. Adult subjects (age ≥ 18 years); 2. No clinical evidence of active cardiac or systemic disease, as confirmed by medical history review, physical examination, and electrocardiogram (ECG). 3. Able to understand the study procedures and provide written informed consent. 3.2 Exclusion Criteria: Subjects will be excluded based on any of the following: 1. History or current diagnosis of any significant cardiac, hepatic, renal, or neurological disorder. 2. Pregnancy or breastfeeding. 3. Any condition that, in the opinion of the investigator, could pose an increased risk from the study procedure or interfere with the interpretation of study data.

ClinicalTrials.gov record NCT07232459

[18F]FT8 PET Imaging in Immunoglobulin Light Chain Amyloidosis

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

Clinical Study of [18F]FT8 PET/CT in Evaluating Amyloidosis

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

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 and older

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 evaluates a PET tracer called [18F]FT8 in people with systemic or cardiac amyloidosis and in healthy volunteers. Each participant receives a single injection of [18F]FT8 and a PET/CT scan, with clinical exams and laboratory tests before and after. The study measures safety, organ uptake on scans, tracer biodistribution, and radiation dose.

What it is studying. The study is testing the safety of [18F]FT8 in humans and how well the tracer visualizes and quantifies amyloid in organs using standardized uptake values (SUV). It also measures where the tracer distributes in the body and the radiation dose, and compares imaging results with standard clinical tests.

What the researchers hope to learn. To evaluate the safety of [18F]FT8, quantify organ uptake (SUV), describe tracer biodistribution, and calculate radiation dosimetry. To compare [18F]FT8 PET/CT findings with established clinical methods (echocardiography, contrast-enhanced MRI, and laboratory tests) to inform a PET protocol for AL amyloidosis.

What this study is about

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

[18F]FT8, a derivative of 1-(4-pyridyl)-4-piperazinyl arene ([18F]TPZA), exhibits high affinity for AL amyloid in myocardial tissue sections and shows no significant binding to transthyretin amyloid. By comparing its diagnostic performance against established clinical methods, including echocardiography, contrast-enhanced MRI, and relevant laboratory tests, this study aims to establish [18F]FT8 as the basis for a robust PET protocol for the direct visualization and differential diagnosis of AL amyloidosis . The study preimarily evaluates the safety and diagnostic efficacy of [18F]FT8 PET imaging in human subjects.

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]FT8

Eligibility

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

Inclusion criteria

Subject Recruitment Participants will be recruited from outpatients and/or inpatient populations of the Hematology Department at Tianjin Medical University General Hospital. The principal investigator and collaborating hematologists will ensure consistent application of diagnosis and enrollment criteria based on standardized guidelines. The planned enrollment includes 20 patients with systemic amyloidosis (including cardiac involvement) and 5 healthy volunteers.
Amyloidosis Patients:
1 Inclusion Criteria:
Subjects must meet all of the following criteria:
Adult patients (age ≥ 18 years);
Suspected, newly diagnosed, or previously diagnosed with cardiac amyloidosis, with supporting evidence from one or more of the following: cardiac MRI, contrast-enhanced CT, serum biomarkers (e.g., NT-proBNP, Troponin), or histopathological confirmation of amyloidosis.
Scheduled to undergo a clinical Pan-Amyloid PET/CT scan as part of standard care or clinical evaluation.
Able to understand the study procedures and provide written informed consent. 2.2

Exclusion criteria

Subjects will be excluded based on any of the following:
Confirmed non-cardiac amyloidosis or other non-amyloid cardiac pathologies that could confound image interpretation.
Pregnancy or breastfeeding.
Any medical, psychological, or social condition that, in the opinion of the investigator, would compromise the subject's ability to participate fully or complete the study follow-up.
Healthy Volunteers: 3.1 Inclusion Criteria:
Subjects must meet all of the following criteria:
Adult subjects (age ≥ 18 years);
No clinical evidence of active cardiac or systemic disease, as confirmed by medical history review, physical examination, and electrocardiogram (ECG).
Able to understand the study procedures and provide written informed consent. 3.2 Exclusion Criteria:
Subjects will be excluded based on any of the following:
History or current diagnosis of any significant cardiac, hepatic, renal, or neurological disorder.
Pregnancy or breastfeeding.
Any condition that, in the opinion of the investigator, could pose an increased risk from the study procedure or interfere with the interpretation of study data.

Study description and what participation involves

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

Detailed description from the registry

Subjects will undergo [18F]FT8 PET/CT scans for safety and diagnostic efficacy evaluation. Organ uptake will be quantified using the standard uptake value (SUV). Clinical assessments and laboratory tests, including baseline information collection, physical examination, cardiac function assessment, and hepatic and renal function tests, will be conducted before and after the scan.

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.

[18F]FT8 PET/CT requires a single intravenous injection of the tracer followed by a PET/CT scan (the record specifies ~10 ± 3 mCi). Before and after the scan you will have baseline information collected, a physical exam, cardiac assessments, and blood tests for liver and kidney function. Study staff will monitor safety and collect any adverse events for up to 7 days after injection (vital signs, exams, and laboratory tests). Organ uptake of the tracer will be measured from the scan images.

How the study is structured. A prospective observational cohort study. Each participant has one intravenous injection of [18F]FT8 followed by a PET/CT scan, with baseline clinical assessment and laboratory tests and safety monitoring up to 7 days after injection.

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 AL amyloidosis and 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: Jul 21, 2025
Primary completion: Jul 20, 2028 (estimated)
Study completion: Dec 20, 2028 (estimated)
Target enrollment: 25 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.

Haonan Yu 📞 +8613821000597 ✉ dreamadam@126.com

Participating sites (3)

The First Affiliated Hospital of University of Science and Technology of ChinaRecruiting
Hefei, Anhui, 230000 · China
- Qiang Xie · +8613721108043 · ahxq1980@163.com
The Affiliated Hospital of Qingdao UniversityRecruiting
Qingdao, Shandong, 266000 · China
- Guangjie Yang, MD · +8617853297979 · ygj_2815@qdu.edu.cn
Tianjin Medical University General HospitalRecruiting
Tianjin, Tianjin Municipality, 350005 · China
- Haonan Yu · +8613821000597 · dreamadam@126.com

Terms used on this page · explanations by MedicalUpdates.ai

echocardiography: An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
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.
PET: 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.
principal investigator: The doctor or scientist responsible for running the study at a site or overall.
enrollment: The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
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.
CT: 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.
biomarkers: Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
written 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.
follow-up: The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
electrocardiogram: A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
baseline: Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.

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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