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| Name | Class |
|---|---|
| Tianjin Medical University General Hospital | OTHER |
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In the field of diagnosing brain neurodegenerative diseases, it is now a well-established practice to inject positron-emitting tracers into the human body. These tracers bind to specific target proteins, allowing their distribution to be visualized via PET imaging. Currently, several research groups worldwide are engaged in developing and clinically validating their own tau imaging agents.
This clinical research project aims to visualize abnormal tau pathology in the living human brain using [18F]NIDF PET imaging. [18F]NIDF is a 2-arene-azaindole-based tracer that offers stronger binding affinity to tau neurofibrillary tangles and reduced non-specific/off-target binding compared to existing tau-PET imaging agents. The study primarily focuses on evaluating the safety and diagnostic efficacy of [18F]NIDF PET imaging in human subjects.
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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]NIDF followed by a PET/CT scan. | ||
| Patients with cognitive impairment | Participants will receive a single intravenous bolus injection of 10 ± 3 mCi of [18F]NIDF followed by a PET/CT scan. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessment | The incidence of adverse events assessed by the investigator as related to the [18F]NIDF 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 |
| The Biodistribution of [18F]NIDF in subjects | Semi-quantitatively evaluate the tracer's uptake in the interest brain regions, like cortical cortex, hippocampus and cerebellum, by measuring the Standard Uptake Value (SUV) or % inject dose per volum (%ID/cc). | At the time of the single [18F]FT8 PET/CT scan (Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Performance | Diagnostic performance including sensitivity, specificity, accuracy. Quantification of [18F]NIDF uptake in different brain regions (e.g., amygdala, temporal lobe, hippcampus) 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 in both two groups. | From enrollment to the end of PET/CT sacns at 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Wang, MD | Contact | +8618702292537 | macrossplusvoices@163.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 |
|---|---|
| D019636 | Neurodegenerative Diseases |
| D024801 | Tauopathies |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Tianjin Medical University General Hospital | Recruiting | Tianjin | Tianjin Municipality | 350005 | China |
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| D019965 |
| Neurocognitive Disorders |
| D001523 | Mental Disorders |