RECRUITINGEarly Phase 1INTERVENTIONAL
Head-to-head Comparison of [18F]F-PSMA-N5 With [68Ga]Ga-PSMA-11 PET/CT in PCa Diagnosis, Recurrence, and Metastasis
Head-to-head Comparison of [18F]F-PSMA-N5 With [68Ga]Ga-PSMA-11 PET/CT in Prostate Cancer Diagnosis, Recurrence, and Metastasis: a Prospective Study
About This Trial
To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent \[18F\]F-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 \[68Ga\]Ga-PSMA-11.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 \[68Ga\]Ga-PSMA-11 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 willing to sign a consent form.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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 \[68Ga\]Ga-PSMA-11 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.
Treatments Being Tested
DRUG
[18F]F-PSMA-N5
Each subject receive a single intravenous injection of \[18F\]F-PSMA-N5, and undergo PET/CT imaging within the specificed time.
DRUG
[68Ga]Ga-PSMA-11
Each subject receive a single intravenous injection of \[68Ga\]Ga-PSMA-11, and undergo PET/CT imaging within the specificed time.
Locations (1)
The First Affiliated Hospital of China University of Science and Technology（Anhui Provincial Hospital）
Hefei, Anhui, China