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Search / Trial NCT06462508

Head-to-head Comparison of [18F]F-PSMA-N5 With [68Ga]Ga-PSMA-11 PET/CT in PCa Diagnosis, Recurrence, and Metastasis

Launched by ANHUI PROVINCIAL HOSPITAL · Jun 12, 2024

Trial Information

Current as of August 20, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging agent called [18F]F-PSMA-N5 to see how well it works for diagnosing prostate cancer, checking for recurrence, and finding any spread of the disease. Researchers want to compare this new agent with an existing one, [68Ga]Ga-PSMA-11, to understand which is better at providing clear images of prostate cancer in the body. The trial is currently recruiting male participants aged 18 to 90 who have been diagnosed with prostate cancer or are suspected of having a recurrence after treatment.

If you decide to participate, you'll undergo imaging tests using both agents within a two-week period. You'll need to provide some medical history, including MRI images and PSA levels, and be willing to have a biopsy if necessary. It's important to note that there are some conditions that might prevent you from joining, such as certain health issues or if you have other cancers. Overall, this trial aims to improve the way prostate cancer is diagnosed and monitored, which could lead to better outcomes for patients.

Gender

MALE

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 \[68Ga\]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.

About Anhui Provincial Hospital

Anhui Provincial Hospital is a leading medical institution in China, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital leverages its extensive expertise in various medical fields to enhance patient outcomes and contribute to the global body of medical knowledge. With a focus on translating research findings into practical applications, Anhui Provincial Hospital is dedicated to fostering collaboration among healthcare professionals and researchers, ensuring that cutting-edge treatments and interventions are accessible to the communities it serves.

Locations

Hefei, Anhui, China

Patients applied

0 patients applied

Trial Officials

Qiang Xie

Study Chair

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported