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Head-to-head Comparison of [18F]F-PSMA-N5 With [18F]F-PSMA-1007 PET/CT in PCa Diagnosis, Recurrence, and Metastasis
NCT06462495 · Anhui Provincial Hospital
In plain English
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Official title
Head-to-head Comparison of [18F]F-PSMA-N5 With [18F]F-PSMA-1007 PET/CT in Prostate Cancer Diagnosis, Recurrence, and Metastasis: a Prospective Study
About this study
\[18F\]F-PSMA-N5 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 \[18F\]F-PSMA-1007 PET/CT.
Eligibility criteria
Inclusion Criteria:
* Aged from 18 to 90 years old;
* Complete MRI images and clinical data (such as PSA level, Gleason grade, etc.);
* Prostate cancer detected by PSA or imaging examination, or clinically suspected recurrence after standardized treatment;
* simultaneous \[18F\]F-PSMA-N5 and \[18F\]F-PSMA-1007 examinations within two weeks;
* Willing to undergo surgery or needle biopsy for pathological examination after examination, or confirmed as prostate cancer by histopathology before or after treatment;
* Sign informed consent.
Exclusion Criteria:
* Patients who cannot cooperate with the examination;
* Concurrent malignant tumors;
* Previous alcohol allergy;
* Patients with liver and kidney dysfunction;
* Other circumstances deemed by the investigator to be inappropriate for trial participation.
Study design
Enrollment target: 30 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-04-10
Estimated completion: 2025-12-31
Last updated: 2024-06-17
Interventions
Drug: [18F]F-PSMA-N5Drug: [18F]F-PSMA-1007
Primary outcomes
- • Standard uptake value(SUV) (30 days)
Sponsor
Anhui Provincial Hospital · other_gov
Contacts & investigators
ContactQiang Xie, MD · contact · xieqiang1980@ustc.edu.cn · +8613721108043
InvestigatorQiang Xie · study_chair, The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
All locations (1)
The First Affiliated Hospital of China University of Science and Technology（Anhui Provincial Hospital）Recruiting
Hefei, Anhui, China