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To evaluate the efficacy of targeted CAIX-specific probe PET imaging in the diagnosis and staging of kidney cancer, as well as to assess its role in prognosis prediction and treatment evaluation for kidney cancer.
Images will be analyzed by at least two physicians with extensive experience in nuclear medicine and radiological diagnostics. Regions of interest (ROIs) will be delineated for the lesion tissues to measure volume and SUV values. The interpreted PET/CT imaging results will be compared to the corresponding histopathological results of the lesions (obtained through biopsy or surgery) and will be used as the reference standard. We will employ McNemar's test to compare the sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of targeted CAIX PET/CT imaging and enhanced CT in primary tumors, metastatic lymph nodes, and distant metastatic lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: CAIX-PET/CT | Each participant receives a single intravenous injection of CAIX-PET/CT, and undergo PET/CT imaging within the specified time. |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the clinical diagnostic efficacy | To evaluate the clinical diagnostic efficacy (sensitivity, specificity, accuracy) of targeted CAIX PET/CT imaging in the diagnosis and staging of kidney cancer | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the clinical added value | To assess the clinical added value of targeted CAIX PET/CT molecular imaging technology in the diagnosis and staging of kidney cancer by comparing it with enhanced CT. | 6 Months |
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Inclusion Criteria:
Voluntary participation with the patient or their legal representative able to sign the informed consent form.
Adult patients (age between 18 and 75 years), regardless of gender.
Patients with clinically suspected or confirmed primary kidney cancer (supporting evidence includes imaging data and histopathological examination; specific case types include clear cell carcinoma, papillary renal cell carcinoma, and chromophobe renal cell carcinoma) who agree to undergo histopathological examination (if not already performed prior to imaging).
Patients must have undergone enhanced CT, with the enhanced CT examination conducted within 2 weeks prior to enrollment.
ECOG performance status score of 0-3.
Laboratory parameters must meet the following criteria:
Willing and able to comply with follow-up visits, treatment plans, and related laboratory examinations.
Exclusion Criteria:
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Adult patients (age between 18 and 75 years), regardless of gender.
Patients with clinically suspected or confirmed primary kidney cancer (supporting evidence includes imaging data and histopathological examination; specific case types include clear cell carcinoma, papillary renal cell carcinoma, and chromophobe renal cell carcinoma) who agree to undergo histopathological examination (if not already performed prior to imaging).
Patients must have undergone enhanced CT, with the enhanced CT examination conducted within 2 weeks prior to enrollment.
ECOG performance status score of 0-3.
Laboratory parameters must meet the following criteria:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haojun Chen | Contact | 86-592-2137077 | leochen0821@foxmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xiamen University, Xiamen, Fujian 361000 | Recruiting | Xiamen | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |