Actively Recruiting

Early Phase 1
Age: 18Years - 90Years
MALE
Healthy Volunteers
NCT06462508

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

Led by Anhui Provincial Hospital · Updated on 2024-06-17

30

Participants Needed

1

Research Sites

88 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 90Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged from 18 to 90 years old
  • Complete MRI images and clinical data such as PSA level and Gleason grade
  • Prostate cancer detected by PSA or imaging, or suspected recurrence after treatment
  • Undergo both [18F]F-PSMA-N5 and [68Ga]Ga-PSMA-11 examinations within two weeks
  • Willing to have surgery or needle biopsy for pathology or confirmed prostate cancer by histopathology
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Unable to cooperate with the examination
  • Having other malignant tumors
  • Previous allergy to alcohol
  • Liver and kidney dysfunction
  • Any other condition deemed unsuitable by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of China University of Science and Technology（Anhui Provincial Hospital）

Hefei, Anhui, China, 230000

Actively Recruiting

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Research Team

Q

Qiang Xie, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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