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This prospective, single-center study investigates the biodistribution, dosimetry, safety, diagnostic performance of Al18F-NOTA-FAPI PET imaging in patients with malignant tumor,cardiovascular or immune disease. And evaluates the potential of Al18F-NOTA-FAPI PET imaging in Clinical treatment strategy guidance.
FAP is expected to become an important indicator for predicting tumor prognosis, and also a new target for individualized treatment of various diseases such as tumors, rheumatoid arthritis, myocardial infarction, and thyroid-associated ophthalmopathy. The biological distribution of FAP in healthy adults is not yet clear. It is planned to obtain the normal PET/CT (or PET/MRI) images of healthy subjects after they use this tracer, in order to establish a benchmark for future application in patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Al18F-NOTA-FAPI PET/CT(PET/MRI) | Experimental | Evaluation of dosimetry, safety, diagnostic accuracy, and clinical treatment strategy guidance ability of Al18F-NOTA-FAPI PET/CT(or PET/MRI) in patients with malignant tumor,cardiovascular or immune disease. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Al18F-NOTA-FAPI PET/CT(or PET/MRI) | Other | Participants will receive an intravenous injection of Al18F-NOTA-FAPI, prepared on-site and measured by qualified personnel using a dose calibrator, with readings and time recorded. The radiopharmaceutical will be slowly administered through a three-way stopcock, followed by a flush with 5 mL of normal saline. The recommended dose is approximately 4.81 MBq/kg (0.13 mCi/kg) body weight, with variations depending on drug yield and clinical scheduling. PET/CT(or PET/MRI) imaging are planned 45-90 minutes after administration, with adjustments based on drug yield and equipment availability. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Al18F-NOTA-FAPI | Adverse effects were recorded according to CTCAE (version 5.0) after radiotracer injection and PET scan. | From radiotracer injection to 24 hours post-injection. |
| Diagnostic accuracy of Al18F-NOTA-FAPI PET/CT(PET/MRI) for cardiovascular or immune disease. | SUVmax 、SUVmean and T2 value(MRI)of the heart and the eye muscles will be measured. Two nuclear medicine physicians will independently review the images, and a third physician will adjudicate in case of disagreement to reach a final diagnosis. Surgical pathology results or Long term follow up findings will serve as the reference standard to determine the sensitivity and specificity . | Through study completion, 1-1.5 years . |
| Measure | Description | Time Frame |
|---|---|---|
| SUVmax of normal organs | The biodistribution of Al18F-NOTA-FAPI will be assessed in the following organs: pituitary gland, parotid glands, thyroid glands, lungs, blood pool, liver, spleen, pancreas (including the head and uncinate process), gallbladder, stomach, small intestine, kidneys, and adrenal glands. The SUVmax values for these organs will be measured and documented. | From study completion to 6 months after completion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Huo, MD | Contact | +86 18612672038 | huoli@pumch.cn | |
| Xueqian Yang, MS | Contact | +86 18801349606 | yangxq202508@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | China |
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| Absorbed dose of target organs | Absorbed dose of target organs were calculated using HERMES software. | From study completion to 6 months after completion |
| ID | Term |
|---|---|
| D006111 | Graves Disease |
| D018376 | Cardiovascular Abnormalities |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005094 | Exophthalmos |
| D009916 | Orbital Diseases |
| D005128 | Eye Diseases |
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002318 | Cardiovascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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