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

Early Phase 1UnknownNCT06462508

Anhui Provincial Hospital30 enrolled

Overview

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.

\[18F\]F-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 \[68Ga\]Ga-PSMA-11 PET/CT.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Prostate Cancer PET/CT

Interventions

[18F]F-PSMA-N5DRUG

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

[68Ga]Ga-PSMA-11DRUG

Each subject receive a single intravenous injection of \[68Ga\]Ga-PSMA-11, and undergo PET/CT imaging within the specificed time.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

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

Hefei, Anhui, China

RECRUITING

Outcomes

Primary Outcomes

Standard uptake value(SUV)

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

Time frame: 30 days

Secondary Outcomes

Diagnostic efficacy

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

Time frame: 30 days

Number of lesions

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

Time frame: 30 days

Central Contacts

Qiang Xie, MD

CONTACT

+8613721108043 xieqiang1980@ustc.edu.cn

Data from ClinicalTrials.gov

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