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Ga-68 PSMA-11 PET/CT is known as useful method for localizing recurred tumor lesions in prostate cancer patients with biochemical recurrence [elevated serum prostate specific antigen (PSA) after radical prostatectomy]. The recent digital PET/CT which is known to show better resolution and sensitivity than analogue PET/CT may have better performance for detecting early small recurred tumor lesions. This study is intended to compare the diagnostic performance (detection rate and positive predictive value) of Ga-68 PSMA-11 PET/CT using analogue PET/CT scanner and digital PET/CT scanner in same patients who had biochemical recurrence of prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biochemical Recurrence | Experimental | Prostate cancer patient with biochemical recurrence |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ga-68 PSMA-11 PET/CT imaging | Diagnostic Test | Sequential PET/CT imaging using analog and digital PET/CT scanners after single intravenous injection of Ga-68 PSMA-11 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detection rate and positive predictive value of Ga-68 PSMA-11 PET/CT images of digital PET/CT and analogue PET/CT | Comparison of detection rate and positive predictive value of Ga-68 PSMA-11 PET/CT images of digital PET/CT and analogue PET/CT in biochemical recurrence (BCR) patients | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Detection rate and positive predictive value of Ga-68 PSMA-11 digital and analog PET/CT according to PSA level groups | Comparison of detection rate and positive predictive value of Ga-68 PSMA-11 digital and analog PET/CT according to PSA level groups in BCR patients | 12 months |
| Comparison of SUVs of Ga-68 PSMA-11 digital and analog PET/CT |
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Inclusion Criteria:
Preliminary study - Establishment of Ga-68 PSMA-11 PET/CT imaging conditions (three subjects)
Main study (40 subjects)
Exclusion Criteria:
Preliminary study - Establishment of Ga-68 PSMA-11 PET/CT imaging conditions (three subjects)
Main study (40 subjects)
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| Name | Affiliation | Role |
|---|---|---|
| Jin-Sook Ryu, MD.PhD. | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | Songpa-gu | 05505 | South Korea |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 16, 2024 | |
| Reset | Aug 2, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 16, 2024 | Aug 2, 2024 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Comparison of standardized uptake values (SUVs) of Ga-68 PSMA-11 digital and analog PET/CT |
| 12 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |