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This study aims to evaluate the imaging characteristics of [⁶⁸Ga]Ga-GS24-B2-250-T Injection (abbreviated as ⁶⁸Ga-GS24-B2-250-T), [⁶⁸Ga]Ga-GS24-B2-268-T Injection (abbreviated as ⁶⁸Ga-GS24-B2-268-T), [⁶⁸Ga]Ga-GS24-B2-237-T Injection (abbreviated as ⁶⁸Ga-GS24-B2-237-T), and [⁶⁸Ga]Ga-PSMA-11 Injection (abbreviated as ⁶⁸Ga-PSMA-11) as PET/CT imaging agents in patients with prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-GS24-B2-250-T | Experimental | detect prostate cancer lesions via 68Ga-GS24-B2-250-T PET/CT imaging |
|
| 68Ga-GS24-B2-237-T | Experimental | detect prostate cancer lesions via 68Ga-GS24-B2-237-T PET/CT imaging |
|
| 68Ga-GS24-B2-268-T | Experimental | detect prostate cancer lesions via 68Ga-GS24-B2-268-T PET/CT imaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-GS24-B2-268-T | Diagnostic Test | detect prostate cancer lesions via 68Ga-GS24-B2-268-T PET/CT imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| Standardized Uptake Value for major organs (salivary glands, kidneys, bone marrow, etc.) and tumor lesions (primary and metastatic lesions) | The Standardized Uptake Value (SUVmax and SUVmin) of major organs (salivary glands, kidneys, bone marrow, etc) and tumor lesions (primary and metastatic lesions) is measured by using Positron Emission Tomography/Computed Tomography (PET/CT) imaging technology for both 68Ga-PSMA-11 and other tested tracers. | 5 days |
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Inclusion Criteria:
The subject has fully understood the trial content, process, and potential risks, and has voluntarily signed the informed consent form;
Male subjects aged ≥ 18 years;
Clinically or radiologically assessed as metastatic hormone-sensitive prostate cancer (mHSPC) or metastatic castration-resistant prostate cancer (mCRPC);
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
Presence of positive lesions on ⁶⁸Ga-PSMA-11 PET/CT scan;
Blood routine, renal function, and liver function tests meeting the following criteria:
Expected survival time ≥ 6 months;
From the date of signing the informed consent form until 3 months after administration, the subject and his partner must use effective contraceptive measures, and the subject must avoid sperm donation.
Exclusion Criteria:
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 68Ga-GS24-B2-250-T | Diagnostic Test | detect prostate cancer lesions via 68Ga-GS24-B2-250-T PET/CT imaging |
|
| 68Ga-GS24-B2-237-T | Diagnostic Test | detect prostate cancer lesions via 68Ga-GS24-B2-237-T PET/CT imaging |
|
| 68Ga-PSMA-11 | Diagnostic Test | detect prostate cancer lesions via 68Ga-PSMA-11 PET/CT imaging |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |