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Clinical Trials in Italy / NCT06167629
Recruiting Observational

Monocentric Observational Study on the Diagnostic and Prognostic Role of 18F-PSMA PET (PET/CT and PET/MR) in Prostate Cancer

NCT06167629 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS San Raffaele
Phase
Observational
Started
2022-10-13
Last updated
2023-12-12

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

PET 18F-PSMA

PET 18F-PSMA: Subjects will be subjected to a PET examination according to international guidelines and where requested by the specialist. In particular, patients will be administered the radiopharmaceutical 18 F PSMA. Approximately two hours after administration, the patient is positioned on the PET/CT equipment table and image acquisition begins.

Study summary

The general objective of this retrospective and prospective study is to evaluate the diagnostic and prognostic role of a quantitative analysis of PET images with 18F-PSMA in all stages of the disease in patients with prostate cancer. To this end, both imaging parameters commonly used in clinical practice and the contribution of radiomic features will be investigated. The latter are quantitative features extracted from biomedical images, and are believed to be able to provide information, otherwise impossible to investigate, useful for the characterization of various pathologies. This methodology is very promising, but also recent and therefore little studied and standardized. Our objective is also to investigate how to optimize it from a purely methodological point of view.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * adult male patients; * patients with histopathological diagnosis of prostate cancer undergoing staging or restaging; * patients with clinical indication for PET examination with 18 F-PSMA; Exclusion Criteria: * medical conditions that do not allow the acquisition of PET images; * allergic reactions to iodinated contrast medium or creatinine levels \>2mg/dL.

Primary outcome measure(s)

  • PET with 18F-PSMA for diagnostic accuracy for staging of prostate cancer. — 5 years
    the role of a quantitative-semi-quantitative analysis for the characterization of prostatic pathology in different phases of the disease.

Trial sites (1)

FacilityCityRegionStatus
IRC Milan Italy Recruiting

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Other trials for the same condition

Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Active, not recruiting
Feasibility of Day-surgery Management for Patients Undergoing Robotic Radical Prostatectomy: a Randomized Trial Active, not recruiting
Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC Active, not recruiting
European Registry of Next Generation Imaging in Advanced Prostate Cancer Recruiting
Observational Study of Patients Who Underwent Diagnostic Investigation (Prostate Biopsy) and/or Radical Prostatectomy Surgery. Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06167629 on ClinicalTrials.gov ↗ ← All trials in Italy