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AmyloidNCT07232459

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

An observational study of Amyloid and Cardiac Amyloidosis, run by Tianjin Medical University at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

[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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Amyloid, Cardiac Amyloidosis, Amyloidosis
What is being tested?
[18F]FT8
Type of treatment
Injection or infusion
How many people
25 participants
Where
3 sitesChina
Study dates
21 Jul 2025to 20 Dec 2028
How long will I take part?
7 Days
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Healthy volunteers and patients with confirmed or suspected systemic or cardiac amyloidosis, including cases secondary to hematologic disorders or genetic diseases.

  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.
  4. 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Haonan Yu contact

+8613821000597

dreamadam@126.com

China3 sites, 3 recruiting

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

    Hefei, Anhui, 230000

    Qiang Xie, +8613721108043, ahxq1980@163.com

    Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266000

    Guangjie Yang, MD, +8617853297979, ygj_2815@qdu.edu.cn

    Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 350005

    Haonan Yu, +8613821000597, dreamadam@126.com

    Recruiting

Other trials in China

About this study

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

[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.

Read the detailed description

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.

Being tested
[18F]FT8
Keywords
PET/CT, Cardiac amyloidosis, immunoglobulin light chain
Medical subject headings
Alzheimer Disease, Amyloid Neuropathies, Familial, Amyloidosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [18F]FT8Diagnostic test

    Each subject will receive a single intravenous injection of [18F]FT8 and will undergo PET imaging at a specified time.

Study groups in NCT07232459
Study groupRoleWhat they receive
Healthy participantsParticipants will receive a single intravenous bolus injection of 10 ± 3 mCi of [18F]FT8 followed by a PET/CT scan.
Receives: Diagnostic Test: [18F]FT8
Amyloidosis PatientsParticipants will receive a single intravenous bolus injection of 10 ± 3 mCi of [18F]FT8, followed by a PET/CT scan.
Receives: Diagnostic Test: [18F]FT8

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The safety assessment

    The incidence of adverse events assessed by the investigator as related to the [18F]FT8 injection. Systematically collect and assess all adverse events within 7 days post-injection through physical examinations, vital signs monitoring, clinical laboratory tests (complete blood count, hepatic and renal function). All events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

    Measured: From time of injection up to 7 days post-injection

  2. [18F]FT8 Organ Uptake measured by Standardized Uptake Value (SUV)

    Quantification of [18F]FT8 uptake in major organs (e.g., heart, liver, kidneys) using the Standardized Uptake Value (SUV). This measurement will be performed on the PET/CT scans acquired at a specified time. The outcome will be reported as the SUV for each organ in both amyloidosis patients and control subjects.

    Measured: At the time of the single [18F]FT8 PET/CT scan (Day 1)

Secondary outcomes (2)

  1. The Biodistribution of [18F]FT8 in subjects

    Semi-quantitatively evaluate the tracer's uptake in the interest organs (including heart, liver, kidneys, lungs, brain, bones, thyroid, blood pool, and other related organs) by measuring the Standard Uptake Value (SUV).

    Measured: At the time of the single [18F]FT8 PET/CT scan (Day 1)

  2. Radiation Dosimetry

    Calculate the effective radiation dose (mSv) to various human organs and the whole body.

    Measured: At the time of the single [18F]FT8 PET/CT scan (Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2025
  2. Study start21 Jul 2025
  3. Primary completion20 Jul 2028 (estimated)
  4. Study completion20 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
25 participants (estimated)
Target duration
7 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT07232459
Sponsor's protocol ID
TJMUGH-12
Status last verified
Sep 2026
First submitted
13 Nov 2025
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Amyloid and Cardiac Amyloidosis, run by Tianjin Medical University at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Haonan Yu (+8613821000597, dreamadam@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The safety assessment (time frame: From time of injection up to 7 days post-injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07232459.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.

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