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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

ConditionsProstate CancerPET/CT
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexMale
Age18-90
SponsorAnhui Provincial Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

Patients who cannot cooperate with the examination;

Concurrent malignant tumors;

Previous alcohol allergy;

Patients with liver and kidney dysfunction;

Trial design

Design model

Single group

Treatments tested in this trial

  • [18F]F-PSMA-N5

    Drug

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

  • [68Ga]Ga-PSMA-11

    Drug

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: [18F]F-PSMA-N5 and [68Ga]Ga-PSMA-11 PET/ CT scanExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

1

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
2

Number of lesions

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

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anhui Provincial Hospital

Lead sponsor

Source ClinicalTrials.gov
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