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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-21

Study Completion Date

2028-12-20

Brief Summary

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\[18F\]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.

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Detailed Description

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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.

Conditions

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Amyloid Cardiac Amyloidosis Amyloidosis Healthy Subjects

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy participants

Participants will receive a single intravenous bolus injection of 10 ± 3 mCi of \[18F\]FT8 followed by a PET/CT scan.

[18F]FT8

Intervention Type DIAGNOSTIC_TEST

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

Amyloidosis Patients

Participants will receive a single intravenous bolus injection of 10 ± 3 mCi of \[18F\]FT8, followed by a PET/CT scan.

[18F]FT8

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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[18F]FT8

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

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).

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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes