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68Ga-P16-093 PET Imaging for Diagnosing Prostate Cancer, a Head-to-head Comparison With mpMRI

RECRUITINGPhase 1/2Sponsored by First Affiliated Hospital of Fujian Medical University
Actively Recruiting
PhasePhase 1/2
SponsorFirst Affiliated Hospital of Fujian Medical University
Started2024-10-01
Est. completion2025-12-31
Eligibility
Age18 Years – 80 Years
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07209865

Summary

68Ga-P16-093 is a novel radiotracer targeting PSMA. In this study, we investigated the diagnostic efficacy of 68Ga-P16-093 PET imaging (PET/CT or PET/MRI) in patients with newly diagnosed, treatment-naive prostate cancer, and performed a head-to-head comparison with multi-parameter magnetic resonance imaging (mpMRI).

Eligibility

Age: 18 Years – 80 YearsSex: MALEHealthy volunteers accepted
Inclusion Criteria:

* Biopsy-confirmed adenocarcinoma of the prostate.
* No anti-tumor treatment received prior to the PET imaging.
* Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements.
* Radical prostatectomy scheduled within 28 days after PET imaging.

Exclusion Criteria:

* Patients with other malignant tumors
* Subjects with any medical condition or other circumstance that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.

Conditions2

CancerProstate Cancer (Adenocarcinoma)

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