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This project uses HER2 protein as the target group of radiodrugs to explore the diagnostic efficacy, safety and metabolic characteristics of 68Ga-Her2-affibody in the expression status of HER2, aiming to provide a new imaging method for the determination of HER2 status in breast cancer At the same time, it also provides new methods and means for early diagnosis, accurate staging, recurrence judgment, treatment decision-making and prognosis judgment of malignant tumors such as lung cancer, gastrointestinal cancer and bladder cancer, and provides scientific basis for precise treatment of malignant tumors.
This project uses HER2 protein as the target group of radiodrugs to explore the diagnostic efficacy, safety and metabolic characteristics of 68Ga-Her2-affibody in the expression status of HER2 in whole body cancer lesions, aiming to provide a new imaging method for the determination of HER2 status in breast cancer and supplement more overall information that is difficult to obtain by traditional core needle biopsy. At the same time, it also provides new methods and means for early diagnosis, accurate staging, recurrence judgment, treatment decision-making and prognosis judgment of malignant tumors such as lung cancer, gastrointestinal cancer and bladder cancer, and provides scientific basis for precise treatment of malignant tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-Her2-affibody | Experimental | Subjects with suspected or confirmed breast cancer will receive an intravenous injection of 68Ga-Her2-affibody followed by PET imaging. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-Her2-affibody | Drug | 68Ga-Her2-affibody is injected intravenously with a dose of 0.06-0.08 mCi/kg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The diagnostic efficacy of 68Ga-Her2-affibody PET/CT in the evaluation of breast cancer | the standardized Uptake Value (SUV) of lesions on 68Ga-Her2-affibody PET/CT | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The dosimetry of 68Ga-Her2-affibody | Research on the dose distribution of 68Ga-Her2-affibody in cancer patients by 1-hour dynamic PET/CT acquisition and analyze by the dosimetry software | 1 year |
| Quantitative evaluation of 68Ga-Her2-affibody |
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Inclusion Criteria:
- patients with confirmed or suspected cancer; Signed written informed consent
Exclusion Criteria:
-
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Yin, Dr | Contact | +8610835725252 | jack-yin@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 |
|---|---|---|---|
| 40338302 | Derived | Gao Y, Yin L, Duan X, Fu Z, Liu Q, Chen J, Xin L, Zhu X, Xiang H, Xu L, Ye J, Liu M. HER2-targeted PET/CT imaging provides potential biomarkers for differentiating HER2-zero, -low, and -positive breast cancer. Eur J Nucl Med Mol Imaging. 2025 Oct;52(12):4525-4538. doi: 10.1007/s00259-025-07220-3. Epub 2025 May 8. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Analyze Her2 expression at the imaging level in combination with Her2 expression
| 1 year |
| Correlation with pathological expression | Analyze Her2 expression at the imaging level in combination with Her2 expression in pathological specimens | 1 year |