An Early Phase 1 interventional study of [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 in Prostate Cancer and PET/CT, sponsored by Anhui Provincial Hospital. Recruiting at 1 site in China. Open to male participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-21.
Sponsored by Anhui Provincial Hospital · Early Phase 1, Interventional, and Diagnostic
To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent [68Ga]Ga-PSMA-D5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with [68Ga]Ga-PSMA-11.
[68Ga]Ga-PSMA-D5 PET/CT was used for initial assessment of prostate cancer or detection of recurrence. The maximum standardized uptake value (SUVmax) was used to evaluate tumor uptake. The sensitivity, specificity, the number and accuracy of lesions identified and the distribution of lesions in each organ were calculated and compared with those of [68Ga]Ga-PSMA-11 PET/CT.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 100 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Anhui Provincial Hospital is the lead sponsor of 129 studies on the registry; 95 are open to participants now.
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Exclusion Criteria:
Subjects PET/CT imaging: On any two days for two consecutive weeks, each subject underwent a PET/ CT scan after intravenous injection of \[68Ga\]Ga-PSMA-D5 and \[68Ga\]Ga-PSMA-11.
Drug: [68Ga]Ga-PSMA-D5 · Drug: [68Ga]Ga-PSMA-11
Each subject receive a single intravenous injection of \[68Ga\]Ga-PSMA-D5, and undergo PET/CT imaging within the specificed time.
Also known as: [68Ga]Ga-PSMA-D5 injection
Each subject receive a single intravenous injection of \[68Ga\]Ga-PSMA-11, and undergo PET/CT imaging within the specificed time.
Also known as: [68Ga]Ga-PSMA-11 injection
Standard uptake value(SUV)
Standard uptake value(SUV) of \[68Ga\]Ga-PSMA-D5 and \[68Ga\]Ga-PSMA-11 for each target lesion of subjects.
Time frame: 30 days
Diagnostic efficacy
The sensitivity, specificity and accuracy of \[68Ga\]Ga-PSMA-D5 and \[68Ga\]Ga-PSMA-11 PET/CT were calculated.
Time frame: 30 days
Number of lesions
The number of lesions detected by \[68Ga\]Ga-PSMA-D5 and \[68Ga\]Ga-PSMA-11 PET/CT.
Time frame: 30 days
Plan to share: No
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Anhui Provincial Hospital