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The Nectin-4 protein belongs to the cell adhesion factors family and has a tissue-specific expression spectrum in normal human tissues. However, Nectin-4 is overexpressed in various malignancies, especially those of epithelial origins, such as uroepithelial carcinoma, making Nectin-4 a highly specific and significant imaging target for malignancies.
[68Ga]N188, a novel molecular probe of PET imaging agent that targets Nectin-4, can be used in the diagnosis and research of a wide variety of Nectin-4 high-expression malignancies, including bladder cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [68Ga]N188 | Experimental | Subjects with suspected or confirmed malignancy will receive an intravenous injection of 68Ga-N188 followed by PET imaging. The subjects will also receive a whole-body 18F-FDG PET/CT scan within a one-week period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [68Ga]N188 | Drug | 68Ga-N188 is injected intravenously with a dose of 0.06-0.08 mCi/kg. |
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| Measure | Description | Time Frame |
|---|---|---|
| The diagnostic efficacy of 68Ga-N188 PET/CT in the evaluation of malignant tumors | Compare the standardized Uptake Value (SUV) of lesions on 68Ga-N188 and 18F-FDG PET/CT | 1 year |
| The diagnostic efficacy of 68Ga-N188 PET/CT in the evaluation of malignant tumors | Compare the number of lesions detected by 68Ga-N188 and 18F-FDG PET/CT, based on the pathology or clinical follow-up as gold standard. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The dosimetry of 68Ga-N188 | Research on the dose distribution of 68Ga-N188 in healthy volunteers and cancer patients by 1-hour dynamic PET/CT acquisition and analyze by the dosimetry software | 1 year |
| Quantitative evaluation of 68Ga-N188 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianhua Zhang, Dr. | Contact | +861083572791 | zjhjn820@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38719240 | Derived | Zhang J, Duan X, Chen X, Zhang Z, Sun H, Shou J, Zhao G, Wang J, Ma Y, Yang Y, Tian X, Shen Q, Yu W, He Z, Fan Y, Yang X. Translational PET Imaging of Nectin-4 Expression in Multiple Different Cancers with 68Ga-N188. J Nucl Med. 2024 May 6;65(Suppl 1):12S-18S. doi: 10.2967/jnumed.123.266830. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Evaluation of quantitative parameters of 68Ga-N188, such as time-activity curve.
| 1 year |
| Correlation with pathological expression | Analyze Nectin-4 expression at the imaging level in combination with Nectin-4 expression in pathological specimens | 1 year |