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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
The First Affiliated Hospital of China University of Science and Technology(Anhui Provincial Hospital)
RECRUITING
Hefei
Contact Information
Primary
Qiang Xie, MD
xieqiang1980@ustc.edu.cn
+8613721108043
Time Frame
Start Date: 2024-04-20
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 30
Treatments
Experimental: [18F]F-PSMA-N5 and [68Ga]Ga-PSMA-11 PET/ CT scan
Subjects PET/CT imaging: On any two days for two consecutive weeks, each subject underwent a PET/ CT scan after intravenous injection of \[18F\]F-PSMA-N5 and \[68Ga\]Ga-PSMA-11.
Related Therapeutic Areas
Sponsors
Leads: Anhui Provincial Hospital

This content was sourced from clinicaltrials.gov