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The objective of the study is to construct a noninvasive approach 68Ga-XACP3 PET/CT to detect tumor lesions in patients with prostate cancer and to compare with 68Ga-PSMA PET/CT.
As a new ACP3 targeting PET radiotracer, 68Ga-XACP3 is promising as an excellent imaging agent applicable to prostate cancer. In this research, subjects with prostate cancer or highly suspected recurrence detection underwent contemporaneous 68Ga-XACP3 and standard-of-care imaging (68Ga-PSMA PET/CT) either for an initial assessment or for metastases or highly suspected recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of positive tumor lesions of standard-of-care imaging and 68Ga-PSMA PET/CT were recorded by visual interpretation. The diagnostic accuracy of 68Ga-XACP3 was calculated and compared to standard-of-care imaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-XACP3 | Experimental | Each subject receives a single intravenous injection of 68Ga-XACP3 and undergoes PET/CT imaging within the specified time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic Test: standard-of-care imaging (68Ga-PSMA PET/CT), 68Ga-XACP3 PET/CT | Diagnostic Test | Each subject receives a single intravenous injection of standard-of-care imaging radiopharmaceutical (68Ga-PSMA) and 68Ga-XACP3, and undergoes PET/CT imaging within the specified time. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic efficacy | Description: The sensitivity, specificity, and accuracy of standard-of-care imaging (68Ga-PSMA PET/CT) and 68Ga-XACP3 PET/CT were calculated and compared to evaluate the diagnostic accuracy. | 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of lesions | The numbers of positive primary and metastatic lesions of standard-of-care imaging (68Ga-PSMA PET/CT) and 68Ga-XACP3 PET/CT were recorded by visual interpretation. | 1 years |
| SUV |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liang Zhao | Contact | 86 18818350620 | wzhaoliang01@163.com | |
| Haojun Chen, MD, PhD | Contact | 86 18659285282 | leochen0821@foxmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xiamen University | Recruiting | Xiamen | Fujian | 361000 | China |
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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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|
Standardized uptake value (SUV) of standard-of-care imaging (68Ga-PSMA PET/CT) and 68Ga-XACP3 PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis.
| 1 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |