Head-to-head Comparison of [18F]AlF-PSMA-N5 With [18F]F-DCFPyL PET/CT in PCa Diagnosis, Recurrence, and Metastasis
Recruiting · NCT06756334 · Interventional (participants receive a specific treatment) · Lead sponsor: Anhui Provincial Hospital
View the official record on ClinicalTrials.gov →Interventions studied
[18F]AlF-PSMA-N5[18F]F-DCFPyL
What this trial is about
To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent \[18F\]AlF-PSMA-N5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with \[18F\]F-DCFPyL.
Who can take part
Age range
18 Years to 90 Years
Sex
Male
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
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 \[18F\]AlF-PSMA-N5 and \[18F\]F-DCFPyL 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.
Where it is running
1 location listed.
- The First Affiliated Hospital of China University of Science and Technology（Anhui Provincial Hospital） - Hefei, Anhui, China