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| Name | Class |
|---|---|
| Tianjin Medical University General Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy participants | Participants will receive a single intravenous bolus injection of 10 ± 3 mCi of [18F]FT8 followed by a PET/CT scan. |
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| Amyloidosis Patients | Participants will receive a single intravenous bolus injection of 10 ± 3 mCi of [18F]FT8, followed by a PET/CT scan. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]FT8 | Diagnostic Test | Each subject will receive a single intravenous injection of [18F]FT8 and will undergo PET imaging at a specified time. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From time of injection up to 7 days post-injection |
| [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. | At the time of the single [18F]FT8 PET/CT scan (Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At the time of the single [18F]FT8 PET/CT scan (Day 1) |
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2.1 Inclusion Criteria:
Subjects must meet all of the following criteria:
Subjects will be excluded based on any of the following:
3. Healthy Volunteers: 3.1 Inclusion Criteria:
Subjects must meet all of the following criteria:
Subjects will be excluded based on any of the following:
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Healthy volunteers and patients with confirmed or suspected systemic or cardiac amyloidosis, including cases secondary to hematologic disorders or genetic diseases.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haonan Yu | Contact | +8613821000597 | dreamadam@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of University of Science and Technology of China | Recruiting | Hefei | Anhui | 230000 | China |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D028227 | Amyloid Neuropathies, Familial |
| D000686 | Amyloidosis |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Radiation Dosimetry |
Calculate the effective radiation dose (mSv) to various human organs and the whole body. |
| At the time of the single [18F]FT8 PET/CT scan (Day 1) |
| Tianjin Medical University General Hospital | Recruiting | Tianjin | Tianjin Municipality | 350005 | China |
|
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D017772 | Amyloid Neuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D028226 | Amyloidosis, Familial |
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D057165 | Proteostasis Deficiencies |