Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT06462508

Recruiting

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

Interventional

Phase 1

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

Sponsor: Anhui Provincial Hospital

Last Updated: June 17, 2024
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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.

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Treatment Category

Radiopharmaceuticals

Required Mutations

None

Trial Started

April 20, 2024

Last Updated by Sponsor

June 17, 2024

Estimated Completion

June 30, 2025

Contact Study

Name:Qiang Xie, MD

Email:xieqiang1980@ustc.edu.cn

Phone:+8613721108043

Eligibility

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.

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Design Details

AllocationN/A

Intervention ModelSingle Group Assignment

MaskingNone (Open Label)

Number to Enroll30

Arms & Interventions

Arms

Interventions

Type: Experimental

Description: 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.

Interventions:

[18F]F-PSMA-N5
[68Ga]Ga-PSMA-11

Outcome Measures

Primary Outcome Measures

Standard uptake value(SUV)30 days

Standard uptake value(SUV) of \[18F\]F-PSMA-N5 and \[68Ga\]Ga-PSMA-11 for each target lesion of subjects.

Secondary Outcome Measures

Diagnostic efficacy30 days

The sensitivity, specificity and accuracy of \[18F\]F-PSMA-N5 and \[68Ga\]Ga-PSMA-11 PET/CT were calculated.

Number of lesions30 days

The number of lesions detected by \[18F\]F-PSMA-N5 and \[68Ga\]Ga-PSMA-11 PET/CT.

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Trial Sites

This study has 1 trial site

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

Hefei, Anhui, CN

Name:Qiang Xie, MD

Recruiting

Hefei, Anhui, 230000 CN

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

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