Shanghai General Hospital
Shanghai, China
NCT Number: NCT04158817
To evaluate the dosimetry, safety and the detection rate of 68Ga-THP-PSMA PET/CT for identifying the site of prostate cancer metastasis and relapse. It is also to evaluate the association of clinical/pathologic features and 68Ga-THP-PSMA PET/CT detection rate and compare 68Ga-THP-PSMA PET/CT with other imaging procedure.
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Notify Me18 year–79 year
Male
Interventional
Early Phase 1
Shanghai, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All participants in the study will be injected with 68Ga-THP-PSMA at a dose of 2.11 MBq/kg in a single dose injection.
Other names: 68Ga-THP-PSMA
Patient will be injected with microdose (<100 ug) of THP-PSMA
Other names: THP-PSMA
Time frame: 2 years
The tumor SUVmax of patients will be measured using Region Of Interest.
Time frame: 2 years
The PSA level (ng/mL) of patients will be tested by hemanalysis
Time frame: 2 years
Visual analysis will be carried out by 4 experienced nuclear medicine physicians to observe the uptake of 68Ga-THP-PSMA in prostate malignant lesions. A 4 point method will be used to interpret the scans for abnormalities. It is categorized as such: score 0, no abnormal increased uptake; score 1, low increased uptake; score 2, moderate increased uptake; score 3, high increased uptake. The lesion will be considered positive for malignancy if the score is 2 or higher.
Time frame: 2 years
The IHC results of prostate malignant lesions will be used as golden standard to evaluate the sensitivity and specificity of 68Ga-THP-PSMA PET/CT.
Time frame: 2 years
To evaluate the dosimetry of 68Ga-THP-PSMA, patients (n = 5) will undergo whole-body planar imaging at different time points (10 min, 1 h, 2 h and 3 h after injection) to obtain radiation dosimetry data. A calibration source of 37 MBq at injection time will be placed above the head of each patient to provide quantitative calibration of counts to activity.
Time frame: 2 years
Drug-related adverse reactions will be recorded during the 7-d follow-up period.
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Other
Gallium-68 Labelled THP-PSMA for the Clinical Stage and Restage of Prostate Cancer Patients
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