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NCT Number: NCT06756334

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

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

Hefei, Anhui, 230000, China

Location status: Recruiting

Location contact

Qiang Xie, MD

CONTACT

[email protected]

13721108043

About this study

[18F]AlF-PSMA-N5 PET/CT was used for initial assessment of prostate cancer or detection of recurrence. The maximum standardized uptake value (SUVmax) was used to evaluate tumor uptake. The sensitivity, specificity, the number and accuracy of lesions identified and the distribution of lesions in each organ were calculated and compared with those of [18F]F-DCFPyL PET/CT.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[18F]AlF-PSMA-N5

Drug

Each subject receive a single intravenous injection of [18F]AlF-PSMA-N5, and undergo PET/CT imaging within the specificed time.

[18F]F-DCFPyL

Drug

Each subject receive a single intravenous injection of [18F]F-DCFPyL, and undergo PET/CT imaging within the specificed time.

Primary outcomes

  1. Standard uptake value(SUV)

    Time frame: 30 days

    Standard uptake value(SUV) of [18F]AlF-PSMA-N5 and [18F]F-DCFPyL for each target lesion of subjects.

Secondary outcomes

  1. Diagnostic efficacy

    Time frame: 30 days

    The sensitivity, specificity and accuracy of [18F]AlF-PSMA-N5 and [18F]F-DCFPyL PET/CT were calculated.

  2. Number of lesions

    Time frame: 30 days

    The number of lesions detected by [18F]AlF-PSMA-N5 and [18F]F-DCFPyL PET/CT.

Study contacts

Contact information is provided by the study sponsor or research team.

Qiang Xie, MD

CONTACT

[email protected]

13721108043

Sponsors and collaborators

Lead sponsor

Anhui Provincial Hospital

Other Gov

Registry information

Official study title

Head-to-head Comparison of [18F]AlF-PSMA-N5 With [18F]F-DCFPyL PET/CT in Prostate Cancer Diagnosis, Recurrence, and Metastasis: a Prospective Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 3, 2025
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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