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This study is a single-center, open-label first-in-human clinical study. Patients with clinically suspected or confirmed malignant solid tumors will undergo [68Ga]Ga-FAP PET imaging or [177Lu]Lu-FAP SPECT imaging as well as [18F]FDG PET imaging to determine the presence or absence of lesions, and to assess lesion location, characteristics, and metastasis. Histopathological diagnosis or follow-up results will serve as the reference standard. The diagnostic efficacy of [68Ga]Ga-FAP PET imaging or [177Lu]Lu-FAP SPECT imaging for malignant tumors will be evaluated. Additionally, the study will analyze the biodistribution and dosimetry of [177Lu]Lu-FAP following a single administration, explore the correlation between tumor uptake values on imaging and immunohistochemical FAP expression levels, and evaluate the safety and tolerability of a single low-dose intravenous injection of [68Ga]Ga-FAP or [177Lu]Lu-FAP for diagnostic imaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET/SPECT imaging of novel FAP-targeted probe in malignant neoplasm | Experimental | This project aims to perform integrated SPECT/CT or PET/MR imaging in patients with histologically confirmed malignant neoplasms with high fibroblast activation protein (FAP) expression. This study utilizes a FAP-specific PET/SPECT imaging probe to evaluate the feasibility, accuracy, and clinical value in malignant neoplasm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel FAP-targeted probe | Drug | For Cancer patients, subjects should have targeting FAP scans |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual and standardized uptake values assessment of lesions and biodistribution | At least two experienced nuclear medicine physicians will analyze the images, using histopathological diagnosis or follow-up findings as the reference standard.The standardized uptake value (SUV) of tumor and organs will be measured after a semiquantitative analysis is conducted for each case. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoli Lan, PhD | Contact | 0086-027-83692633 | lxl730724@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhan union hosptital | Wuhan | Hubei | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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